Approved Drugs
Approved Drugs
SUPPLEMENT 10
OCTOBER 2015
APPROVED
DRUG PRODUCTS
WITH
35th EDITION
2015
Prepared By
with
October 2015
CONTENTS
PAGE
1.0 INTRODUCTION ........................................................................................................................................ iii
1.6 Report of Counts for the Prescription Drug Product List .................................................................. vii
Administered by the Center for Biologics Evaluation and Research List ................................... 3-1
with
October 2015
1.0 INTRODUCTION
1.1
iii
New additions to the Prescription Drug Product List and OTC Drug Product
List are indicated by the symbol >A>. The Patent and Exclusivity List
new additions are indicated by the symbol >A> to the left of Patent
Number or Exclusivity Code. The >A> symbol is then dropped in subsequent
Cumulative Supplements for that item.
New deletions to the Prescription Drug Product List and OTC Drug Product
List are indicated by the symbol >D> (DELETE) to the left of the line.
The information line with the >D> symbol is dropped in subsequent
Cumulative Supplements for that item.
The Patent and Exclusivity List is arranged in alphabetical order by
active ingredient name(s) and trade name. The trade name will follow the
active ingredient name separated by a dash symbol. Also shown is the
application number and product number (FDA's internal file number) for
reference purposes. All patents with their expiration dates are
displayed for each application number. Drug substance and drug product
patents are indicated as such with DS or DP in the Patent codes column.
Use patents are indicated with the symbol "U" followed by a number
representing a specific use. Exclusivity information for a specific drug
is indicated by an abbreviation followed by the date upon which the
exclusivity expires. Refer to the Exclusivity Terms, Section B, in the
Patent and Exclusivity Information Addendum for an explanation of all
codes and abbreviations. Refer to Section 1.3 for internet access to the
most current list of Patent and Exclusivity terms.
1.2
iv
1.3
Rockville, MD 20855-2773
1.4
REDKITT BENCKISER
PHARMACEUTICALS INC
(RECKITT BENCKISER)
INDIVIOR INC
(INDIVIOR INC)
LEVOTHYROXINE SODIUM
Because there are multiple reference listed drugs of levothyroxine sodium
tablets and some reference listed drugs' sponsors have conducted studies
v
Trade Name
Applicant
Potency
Appl No
Product No
UNITHROID
LEVOTHYROXINE
SODIUM
LEVOXYL
SYNTHROID
LEVO-T
STEVENS J
MYLAN
0.025MG AB1
0.025MG AB1
TE Code
21210
76187
001
001
21301
21402
21342
001
001
001
SYNTHROID
LEVOTHYROXINE
SODIUM
LEVO-T
UNITHROID
ABBOTT
MYLAN
0.025MG AB2
0.025MG AB2
21402
76187
001
001
21342
21210
001
001
LEVOXYL
LEVO-T
UNITHROID
LEVOTHYROXINE
SODIUM
KUNG PHARMS
ALARA PHARM
STEVENS J
MYLAN
0.025MG
0.025MG
0.025MG
0.025MG
AB3
AB3
AB3
AB3
21301
21342
21210
76187
001
001
001
001
LEVOTHROID
LEVOTHYROXINE
SODIUM
LLOYD
MYLAN
0.025MG AB4
0.025MG AB4
21116
76187
001
001
vii
DEC 2014
MAR 2015
JUN 2015
SEPT 2015
16150
2572
(15.9%)
16352
2608
(15.9%)
16543
2586
(15.6%)
16824
2613
(15.5%)
MULTISOURCE
13578
(84.1%)
13744
(84.1%)
13957
(84.4%)
14211
(84.5%)
THERAPEUTICALLY
EQUIVALENT
13443
(83.2%)
13610
(83.2%)
13832
(83.6%)
14089
(83.7%)
NOT THERAPEUTICALLY
EQUIVALENT
135
(0.8%)
134
(0.8%)
125
(0.8%)
122
(0.7%)
77
(0.5%)
75
(0.5%)
75
(0.5%)
75
(0.4%)
APPROVED
13
22
12
37
NUMBER OF APPLICANTS
927
935
957
975
EXCEPTIONS1
DEC 2015
CAIN
CDFR
CFTG
CMFD
CMS1
CMS2
CPOT
CRLD
CTEC
CTNA
DISC
ix
35TH
1 -1
2015
N 204767
Oct NEWA
A 205120
Oct NEWA
A 089987
A 089987
Oct CTEC
Oct CTEC
A 088616
Feb CAHN
AB
N 020232
Jan CAHN
AA
AA
A 085868
A 087083
001
001
Apr CAHN
Apr CAHN
A 040846
A 040826
Feb CTEC
Apr CAHN
A 040148
A 040148
Feb NEWA
Feb NEWA
>A>
>A> AA
>D>
>A> AA
1GM/100ML (10MG/ML)
ACETAMINOPHEN; BUTALBITAL
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
TEDOR PHARMA INC
325MG;50MG
BUTAPAP
+
MIKART
325MG;50MG
+
325MG;50MG
EDITION
October
ACETAMINOPHEN
SOLUTION;IV (INFUSION)
ACETAMINOPHEN
FRESENIUS KABI USA
10
AA
AA
AB
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
DIAMOX
+
TEVA BRANDED PHARM
500MG
N 012945
001
Jun CAHN
ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
@ ANI PHARMS INC
@
A 070869
A 070870
Jul CAHN
Jul CAHN
A 203173
A 203624
Mar NEWA
Jun NEWA
A 204674
A 203853
Sep CAHN
Sep CAHN
A 202148
A 203707
A 203707
A 202148
A 204633
A 204633
A 204633
001
001
002
002
001
002
003
Aug
Aug
Aug
Aug
May
May
May
AA
AP
AP
AN
AN
AB
AB
AB
AB
AB
AB
AB
250MG
500MG
ACETYLCYSTEINE
INJECTABLE;INTRAVENOUS
ACETYLCYSTEINE
AKORN INC
6GM/30ML (200MG/ML)
MYLAN INSTITUTIONAL
6GM/30ML (200MG/ML)
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
ALVOGEN INC
10%
20%
ACITRETIN
CAPSULE;ORAL
ACITRETIN
MYLAN PHARMS INC
10MG
17.5MG
22.5MG
25MG
10MG
17.5MG
22.5MG
Sep
Sep
Sep
Sep
May
May
May
10,
10,
10,
10,
22,
22,
22,
2015
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
10
1 -2
October
2015
A 204633
May NEWA
N 202450
N 202450
Apr CAHN
Aug CPOT
A 074980
A 074980
Apr CAHN
Apr CAHN
A 203790
Sep NEWA
N 022320
Sep CFTG
N 207917
N 207917
Aug CAHN
Jul NEWA
CAPSULE;ORAL
ACITRETIN
AB
25MG
ACLIDINIUM BROMIDE
POWDER, METERED;INHALATION
TUDORZA PRESSAIR
+
ASTRAZENECA PHARMS
0.375MG/INH
+
0.4MG/INH
AB
AB
AB
AB
AP
AA
ACYCLOVIR
TABLET;ORAL
ACYCLOVIR
SUN PHARM INDS LTD
400MG
800MG
3MG/ML
3MG/ML
3MG/ML
A 076500
A 076501
A 090220
Jun CAHN
Sep CAHN
May DISC
ALBENDAZOLE
TABLET, CHEWABLE;ORAL
ALBENZA
+
AMEDRA PHARMS LLC
200MG
N 207844
Jun NEWA
N 205636
Mar NEWA
A 074454
Apr CAHN
N 020291
May DISC
A 090221
Feb DISC
N 021287
Jun CAHN
N 022545
N 022545
N 022545
N 022545
001
002
003
004
May
May
May
May
ALBUTEROL SULFATE
POWDER, METERED;INHALATION
PROAIR RESPICLICK
+
TEVA BRANDED PHARM
EQ 0.090MG BASE/INH
SYRUP;ORAL
ALBUTEROL SULFATE
G AND W LABS INC
EQ 2MG BASE/5ML
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
COMBIVENT
@ BOEHRINGER INGELHEIM
EQ 0.09MG BASE/INH;0.018MG/INH
AB
ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
@ WOCKHARDT LTD
10MG
UROXATRAL
+
CONCORDIA PHARMS INC
10MG
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
TABLET;ORAL
TEKAMLO
@ NOVARTIS
EQ 150MG BASE;EQ
@
EQ 150MG BASE;EQ
@
EQ 300MG BASE;EQ
@
EQ 300MG BASE;EQ
5MG BASE
10MG BASE
5MG BASE
10MG BASE
Aug
Aug
Aug
Aug
26,
26,
26,
26,
2010
2010
2010
2010
DISC
DISC
DISC
DISC
10
October
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>D> AA
>A>
>D> AA
>A>
ALMOTRIPTAN MALATE
TABLET;ORAL
ALMOTRIPTAN MALATE
MYLAN PHARMS INC
TEVA PHARMS USA
AXERT
JANSSEN PHARMS
+
EQ
EQ
EQ
EQ
001
002
003
004
005
Dec
Dec
Dec
Dec
Dec
21,
21,
21,
21,
21,
2010
2010
2010
2010
2010
May
May
May
May
May
DISC
DISC
DISC
DISC
DISC
Nov
Nov
Jul
Jul
09,
09,
07,
07,
2015
2015
2015
2015
Oct
Oct
Jun
Jun
NEWA
NEWA
NEWA
NEWA
BASE
BASE
BASE
BASE
A 205171
A 205171
A 078027
A 078027
001
002
001
002
EQ 6.25MG BASE
EQ 12.5MG BASE
N 021001
N 021001
Jun CFTG
Jun CFTG
0.5MG BASE
1MG BASE
A 200652
A 200652
Apr NEWA
Apr NEWA
0.5MG BASE
1MG BASE
N 021107
N 021107
Apr CFTG
Apr CFTG
A 074085
A 074085
A 074085
A 074085
A 203346
A 203346
A 203346
A 203346
A 200739
A 200739
A 200739
A 200739
001
002
003
004
001
002
003
004
001
002
003
004
Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Apr
16,
16,
16,
26,
31,
31,
31,
31,
15,
15,
15,
15,
1994
1994
1994
1996
2015
2015
2015
2015
2015
2015
2015
2015
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Mar
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
A 078489
A 078489
A 078489
A 078489
001
002
003
004
Oct
Oct
Oct
Oct
17,
17,
17,
17,
2008
2008
2008
2008
Sep
Sep
Sep
Sep
CAHN
CAHN
CAHN
CAHN
ALOSETRON HYDROCHLORIDE
TABLET;ORAL
ALOSETRON HYDROCHLORIDE
ROXANE
EQ
EQ
LOTRONEX
PROMETHEUS LABS
EQ
+
EQ
6.25MG
12.5MG
6.25MG
12.5MG
1 -3
2015
ALPRAZOLAM
TABLET;ORAL
ALPRAZOLAM
@ ANI PHARMS INC
@
@
@
AUROBINDO PHARMA LTD
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
NATCO PHARMA LTD
0.25MG
0.5MG
1MG
2MG
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
HERITAGE PHARMS INC
0.5MG
1MG
2MG
3MG
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
BANNER LIFE SCIENCES
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
@ G AND W LABS INC
+
SILARX
@
+
VINTAGE
@
100MG
A 078720
Jan CAHN
50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML
A 072655
A 076352
A 076352
A 077992
A 077992
001
001
001
001
001
May
Oct
Oct
Oct
Oct
AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
@ IGI LABS INC
@
EQ 50MG BASE/ML
EQ 250MG BASE/ML
A 063167
A 063169
Oct
Sep
Sep
Dec
Dec
30,
10,
10,
12,
12,
1990
2004
2004
2006
2006
CAHN
DISC
DISC
DISC
DISC
Mar CAHN
Mar CAHN
AB
10
1 -4
October
2015
AMILORIDE HYDROCHLORIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE
ZYDUS PHARMS USA INC
5MG
A 204180
Jul NEWA
AMINO ACIDS
INJECTABLE;INJECTION
BRANCHAMIN 4% IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
4% (4GM/100ML)
N 018684
Feb DISC
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
3.5%;51MG/100ML;131MG/100ML;218MG/ N 020177 001 Oct 23, 1995
Feb DISC
100ML;35MG/100ML
AA
AB
AMINOCAPROIC ACID
SYRUP;ORAL
AMINOCAPROIC ACID
VERSAPHARM INC
TABLET;ORAL
AMINOCAPROIC
VERSAPHARM INC
1.25GM/5ML
A 074759
May CAHN
500MG
A 075602
May CAHN
A 084910
A 085031
A 085032
A 085030
003
001
001
001
Aug
Aug
Aug
Aug
N 016949
001
Jul CAHN
N 016949
002
Jul CAHN
A 090752
A 090752
A 078224
A 078224
A 078224
A 204900
A 204900
A 204900
A 077974
A 077974
A 077974
001
002
001
002
003
001
002
003
001
002
003
Apr
Apr
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul
15,
15,
27,
27,
27,
23,
23,
23,
09,
09,
09,
2011
2011
2008
2008
2008
2015
2015
2015
2007
2007
2007
Mar
Mar
Sep
Sep
Sep
Jul
Jul
Jul
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
A 200797
A 200797
A 200797
A 200797
A 200797
A 201087
A 201087
A 201087
A 201087
A 201087
A 200435
A 200435
A 200435
A 200435
001
002
003
004
005
001
002
003
004
005
001
002
005
003
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
03,
03,
03,
03,
03,
01,
01,
01,
01,
01,
25,
25,
25,
25,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2012
2012
2012
2012
May
May
May
May
May
May
May
May
May
May
May
May
May
May
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAIN
CAIN
CAIN
CAIN
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
@ ANI PHARMS INC
10MG
@
25MG
@
50MG
@
75MG
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
LIMBITROL
@ HERITAGE PHARMS INC
EQ 12.5MG BASE;5MG
LIMBITROL DS
@ HERITAGE PHARMS INC
EQ 25MG BASE;10MG
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
CHINA RESOURCES
MYLAN PHARMS INC
SOVEREIGN PHARMS
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
CAHN
CAHN
CAHN
CAHN
2015
A 200435
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
004
001
001
002
002
003
003
004
004
005
005
N 205003
N 205003
N 205003
Jan NEWA
Jan NEWA
Jan NEWA
A 202713
A 202713
A 202713
A 202713
A 090245
A 090245
A 090245
A 090245
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 202829
A 202829
A 202829
A 202829
A 091235
A 091235
A 091235
A 091235
A 202377
A 202377
A 202377
A 202377
001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
002
003
004
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
>A> AP
AP
AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
3D IMAGING DRUG
BIOMEDCL RES FDN
A 203779
A 204352
Oct NEWA
Apr NEWA
AP
CENTRAL RADIOPHARM
IBA MOLECULAR N AM
A 204539
A 204667
Jun NEWA
Apr NEWA
A 204515
A 204510
A 204547
A 204455
001
001
001
001
Jan
Oct
Aug
Apr
A 065016
A 065016
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AP
AP
AB
AB
1 -5
October
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
10
TABLET;ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
10MG;25MG;320MG
TORRENT PHARMS LTD
5MG;12.5MG;160MG
5MG;12.5MG;160MG
5MG;25MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
10MG;25MG;320MG
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
48.75mCi-487.5mCi/13ML (3.7537.5mCi/ML)
3.75-260mCi/ML
18.8mCi-188mCi/5ML (3.7537.5mCi/ML)
3.75-260mCi/mL
30mCi-300mCi (3.75-37.5mCi/ML)
3.75-260mCi/ML
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
250MG
500MG
Sep
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Feb
Nov
Aug
Apr
25,
03,
04,
03,
04,
03,
04,
03,
04,
03,
04,
03,
03,
03,
03,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
04,
02,
14,
23,
2012
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
May
Sep
May
Sep
May
Sep
May
Sep
May
Sep
May
CAIN
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
Apr CAHN
Apr CAHN
AB
AB
AB
FOR SUSPENSION;ORAL
AMOXICILLIN
@ SUN PHARM INDS LTD
@
TABLET;ORAL
AMOXICILLIN
SUN PHARM INDS LTD
TABLET, CHEWABLE;ORAL
AMOXICILLIN
SUN PHARM INDS LTD
@
AB
@
AB
AB
AB
AB
AB
AB
1 -6
October
2015
200MG/5ML
400MG/5ML
A 065113
A 065113
Apr CAHN
Apr CAHN
500MG
875MG
A 065059
A 065059
Apr CAHN
Apr CAHN
125MG
200MG
250MG
400MG
A 065021
A 065060
A 065021
A 065060
001
001
002
002
Apr
Apr
Apr
Apr
A 065132
A 065132
A 065207
Apr CAHN
Apr CAHN
Apr CAHN
A 065109
A 065102
Apr CAHN
Apr CAHN
A 065161
A 065161
Apr CAHN
Apr CAHN
N 208147
Oct NEWA
10
Dec
Nov
Dec
Nov
23,
29,
23,
29,
1999
2000
1999
2000
CAHN
CAHN
CAHN
CAHN
>A>
>A>
>A>
AMPHETAMINE
SUSPENSION, EXTENDED RELEASE;ORAL
DYANAVEL XR
+
TRIS PHARMA INC
EQ 2.5MG BASE/ML
>A>
>A>
>A>
>A>
>A>
>A>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AMPHETAMINE SULFATE
TABLET;ORAL
EVEKEO
ARBOR PHARMS LLC
+
AP
AP
AP
AP
AP
>A> AP
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
HOSPIRA INC
SAGENT PHARMS
5MG
10MG
A 200166
A 200166
Mar CTNA
Mar CTNA
EQ
EQ
EQ
EQ
EQ
EQ
A 202864
A 202864
A 202864
A 202864
A 202865
A 090581
001
002
003
004
001
001
Aug
Aug
Aug
Aug
Aug
Oct
A 061741
001
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
10GM BASE/VIAL
Sep
Sep
Sep
Sep
Sep
Oct
04,
04,
04,
04,
04,
20,
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
Apr CAHN
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
@ KREMERS URBAN PHARMS
AP
AP
AP
AA
AA
AA
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
ARGATROBAN
INJECTABLE;INJECTION
ARGATROBAN
FRESENIUS KABI USA
+
PFIZER
INJECTABLE;IV (INFUSION)
ARGATROBAN
FRESENIUS KABI USA
ARIPIPRAZOLE
SOLUTION;ORAL
ARIPIPRAZOLE
AMNEAL PHARMS
APOTEX INC
SILARX PHARMS INC
TABLET;ORAL
ABILIFY
OTSUKA
+
+
ARIPIPRAZOLE
ALEMBIC PHARMS LTD
1 -7
October
2015
1MG
A 091331
Mar CAHN
250MG/2.5ML (100MG/ML)
250MG/2.5ML (100MG/ML)
N 201811
N 020883
Apr CDFR
Aug CTNA
250MG/2.5ML (100MG/ML)
N 201811
Mar NEWA
1MG/ML
1MG/ML
1MG/ML
A 203906
A 204094
A 204171
Aug NEWA
Sep NEWA
Aug NEWA
2MG
5MG
10MG
15MG
20MG
30MG
N 021436
N 021436
N 021436
N 021436
N 021436
N 021436
006
005
001
002
003
004
Nov
Nov
Nov
Nov
Nov
Nov
15,
15,
15,
15,
15,
15,
2002
2002
2002
2002
2002
2002
Apr
Apr
Apr
Apr
Apr
Apr
CFTG
CFTG
CFTG
CFTG
CFTG
CFTG
A 202101
A 202101
A 202101
A 202101
A 202101
A 202101
A 078583
A 078583
A 078583
A 078583
A 078583
A 078583
A 203908
A 203908
A 203908
A 203908
A 203908
A 203908
A 205064
A 205064
A 205064
A 205064
A 205064
A 205064
A 078607
A 078607
A 078608
A 078708
A 078708
A 078708
A 201519
A 201519
A 201519
A 201519
A 201519
A 201519
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
001
001
002
003
001
003
002
004
005
006
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
28,
28,
28,
28,
28,
28,
24,
24,
24,
24,
24,
24,
08,
08,
08,
08,
08,
08,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
N 021729
N 021729
Apr CFTG
Apr CFTG
A 202102
A 202102
Apr NEWA
Apr NEWA
2MG
5MG
10MG
15MG
20MG
30MG
APOTEX INC
2MG
5MG
10MG
15MG
20MG
30MG
AUROBINDO PHARMA LTD
2MG
5MG
10MG
15MG
20MG
30MG
HETERO LABS LTD V
2MG
5MG
10MG
15MG
20MG
30MG
TEVA PHARMS USA
2MG
5MG
10MG
15MG
20MG
30MG
TORRENT PHARMS LTD
2MG
10MG
5MG
15MG
20MG
30MG
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
+
OTSUKA
10MG
15MG
ARIPIPRAZOLE
ALEMBIC PHARMS LTD
10MG
15MG
10
>A>
>A>
>A>
>A>
>A>
>A>
ARIPIPRAZOLE LAUROXIL
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
ARISTADA
ALKERMES INC
441MG/1.6ML (275.63MG/ML)
662MG/2.4ML (275.83MG/ML)
+
882MG/3.2ML (275.63MG/ML)
10
October
2015
N 207533
N 207533
N 207533
1 -8
Oct NEWA
Oct NEWA
Oct NEWA
0MG/VIAL;4MG/VIAL;3.6MG/VIAL;3MG/V
IAL;1MG/VIAL;10MG/VIAL
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM
SULFATE
FOR SOLUTION;ORAL
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
@ NOVEL LABS INC
4.7GM;100GM;1.015GM;5.9GM;2.691GM; A 090145 001 Jan 25, 2012
Aug CTNA
7.5GM
ASENAPINE MALEATE
TABLET;SUBLINGUAL
SAPHRIS
FOREST LABS LLC
+
EQ 5MG BASE
EQ 10MG BASE
N 022117
N 022117
Jun CAHN
Jun CAHN
N 200671
Sep NEWA
N 017534
Jan CAHN
N 017534
Jan CAHN
A 203335
Oct NEWA
N 019429
Jan CAHN
N 011483
Aug CAHN
A 074654
A 074654
Mar CTEC
Mar CTEC
A 090084
Mar CAHN
ASPIRIN
CAPSULE, EXTENDED RELEASE;ORAL
DURLAZA
+
NEW HAVEN PHARMS
162.5MG
ASPIRIN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
FIORINAL
AA
+
ACTAVIS LABS UT INC
325MG;50MG;40MG
TABLET;ORAL
FIORINAL
@ ACTAVIS LABS UT INC
325MG;50MG;40MG
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
>A> AB
COASTAL PHARMS
325MG;50MG;40MG;30MG
FIORINAL W/CODEINE
AB
+
ACTAVIS LABS UT INC
325MG;50MG;40MG;30MG
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AP
ATENOLOL
TABLET;ORAL
ATENOLOL
ALVOGEN IPCO SARL
2015
N 206353
Jan NEWA
25MG
50MG
100MG
25MG
A 073646
A 072303
A 072304
A 074099
001
001
001
001
Jul
Jul
Jul
Jun
25MG
50MG
100MG
N 018240
N 018240
N 018240
Feb CAHN
Feb CAHN
Feb CAHN
A 072301
A 072302
Jul CAHN
Jul CAHN
N 018760
Feb CAHN
N 018760
Feb CAHN
ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
ALVOGEN IPCO SARL
50MG;25MG
100MG;25MG
TENORETIC 100
+
ALVOGEN IPCO SARL
100MG;25MG
TENORETIC 50
ALVOGEN IPCO SARL
50MG;25MG
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
KREMERS URBAN PHARMS
1 -9
October
10
Jul
Jul
Jul
Apr
31,
15,
15,
28,
1992
1988
1988
1992
CAHN
CAHN
CAHN
DISC
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
A 091624
A 091624
A 091624
A 091624
A 076477
A 076477
A 076477
A 076477
001
002
003
004
001
002
003
004
Apr
Apr
Apr
Apr
Nov
Nov
Nov
Nov
05,
05,
05,
05,
30,
30,
30,
30,
2013
2013
2013
2013
2011
2011
2011
2011
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
10MG
20MG
40MG
80MG
BASE;10MG
BASE;10MG
BASE;10MG
BASE;10MG
N 200153
N 200153
N 200153
N 200153
001
002
003
004
May
May
May
May
03,
03,
03,
03,
2013
2013
2013
2013
May
May
May
May
DISC
DISC
DISC
DISC
A 091211
Mar NEWA
A 206011
Mar NEWA
A 206010
Mar NEWA
N 206289
May CRLD
N 017744
002
Feb CAHN
N 017744
001
Feb CAHN
October
2015
1 -10
A 086727
001
Jul CAHN
N 206494
Feb NEWA
AZELAIC ACID
AEROSOL, FOAM;TOPICAL
FINACEA
+
BAYER HLTHCARE
N 207071
Jul NEWA
A 090176
Jul NEWA
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
A 065488
A 065488
May NEWA
May NEWA
EQ 500MG BASE/VIAL
A 203294
Jun NEWA
EQ 250MG BASE
EQ 500MG BASE
EQ 600MG BASE
A 065398
A 065399
A 065400
May NEWA
May NEWA
May NEWA
750MG
N 020610
Jul CAHN
1.1GM
A 206336
Aug NEWA
1.1GM
1.1GM
N 022205
N 022205
Aug CFTG
Jul CAHN
AB
AB
AB
AB
AB
AB
AB
AB
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
AMNEAL PHARMS LLC
5MG
10MG
20MG
40MG
SUN PHARM INDS LTD
5MG
10MG
20MG
40MG
A 076820
A 076820
A 076820
A 076820
A 076344
A 076344
A 076344
A 076344
001
002
003
004
001
002
003
004
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
03,
03,
03,
03,
11,
11,
11,
11,
2006
2006
2006
2006
2004
2004
2004
2004
Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
AB
A 077483
A 077483
A 077483
A 077483
001
002
003
004
Sep
Sep
Sep
Sep
08,
08,
08,
08,
2005
2005
2005
2005
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
AP
AB
AB
AB
AB
AB
AB
15%
AZELASTINE HYDROCHLORIDE
SPRAY, METERED;NASAL
AZELASTINE HYDROCHLORIDE
BRECKENRIDGE PHARMS
EQ 0.125MG BASE/SPRAY
AZITHROMYCIN
FOR SUSPENSION;ORAL
AZITHROMYCIN
LUPIN LTD
INJECTABLE;INJECTION
AZITHROMYCIN
AUROBINDO PHARMA LTD
TABLET;ORAL
AZITHROMYCIN
LUPIN LTD
BALSALAZIDE DISODIUM
CAPSULE;ORAL
COLAZAL
+
VALEANT PHARMS INTL
TABLET;ORAL
BALSALAZIDE DISODIUM
PAR PHARM INC
GIAZO
+
VALEANT PHARMS INTL
+
10
2015
A 091310
A 091310
A 081297
A 081297
A 202765
A 091133
A 091133
A 091133
A 091133
001
002
001
002
001
001
002
001
002
N 050819
Jun CFTG
A 205128
A 202440
Jun NEWA
Sep NEWA
N 050819
Jan CRLD
A 065385
Sep NEWA
A 090968
Jun CRLD
N 012427
002
Jun DISC
A 204713
A 204713
A 204713
Mar NEWA
Mar NEWA
Mar NEWA
BETAMETHASONE DIPROPIONATE
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
G AND W LABS INC
EQ 0.05% BASE
@
EQ 0.05% BASE
A 071467
A 071882
Apr CAHN
Apr CAHN
>A>
>A>
>A>
N 207589
Oct NEWA
>A> AB
A 202894
Oct NEWA
EQ 0.1% BASE
N 018642
Aug CAHN
EQ 0.1% BASE
A 070072
Apr CAHN
EQ 0.1% BASE
EQ 0.1% BASE
A 070069
A 070069
Oct CAHN
Oct CAHN
AA
AA
AA
AA
AA
AA
AA
AA
AA
AB
AB
AB
AB
AA
AA
AA
AA
AB
AB
AB
>A> AB
>D>
100MG
200MG
100MG
200MG
200MG
100MG
200MG
100MG
200MG
BETAMETHASONE VALERATE
CREAM;TOPICAL
BETA-VAL
G AND W LABS INC
LOTION;TOPICAL
BETA-VAL
G AND W LABS INC
OINTMENT;TOPICAL
BETA-VAL
G AND W LABS INC
@ TEVA
0.5MG
1MG
2MG
1 -11
October
BENZONATATE
CAPSULE;ORAL
BENZONATATE
APOTEX INC
10
Jan
Jan
Jan
Oct
Jul
Jul
Jul
Jul
Jul
16,
16,
29,
30,
31,
30,
30,
30,
30,
2015
2015
1993
2007
2015
2015
2015
2015
2015
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Aug
Aug
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
NEWA
CAHN
CAHN
AA
AA
AA
AA
AA
AA
BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
HERITAGE PHARMA
AA
AA
AA
10
1 -12
October
2015
5MG
10MG
25MG
50MG
5MG
50MG
A 091256
A 091256
A 091256
A 091256
A 040703
A 040677
001
002
003
004
001
001
10MG
25MG
50MG
A 086262
A 086263
A 085882
001
001
003
Jan CMFD
May CMFD
May CMFD
75MG
75MG
A 203174
A 203174
Jun CMFD
Jan CAHN
75MG
N 021055
Jun CTEC
May
May
May
May
Mar
Mar
04,
04,
04,
04,
27,
27,
2010
2010
2010
2010
2008
2008
Mar
Mar
Mar
Mar
Feb
Feb
CAHN
CAHN
CAHN
CAHN
CMFD
CMFD
AB
BEXAROTENE
CAPSULE;ORAL
BEXAROTENE
BANNER LIFE SCIENCES
@
TARGRETIN
+
VALEANT LUXEMBOURG
AB
AB
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
APOTEX INC
STASON PHARMS
50MG
50MG
A 200274
A 091011
May NEWA
May NEWA
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
BIMATOPROST
ALCON RES LTD
APOTEX INC
+
LUPIN LTD
+
+
0.03%
0.03%
0.03%
0.03%
0.03%
A 202565
A 090449
A 203991
A 203991
A 203991
001
001
001
001
001
Apr
Jul
Apr
Mar
Feb
BIPERIDEN HYDROCHLORIDE
TABLET;ORAL
AKINETON
@ ABBVIE
2MG
N 012003
001
Aug DISC
N 050786
Jul CAHN
250MG/VIAL
250MG/VIAL
A 090811
A 090816
Jun NEWA
Jun NEWA
EQ 100MG BASE
EQ 500MG BASE
N 203341
N 203341
Jun CRLD
Jun CRLD
0.25MG
0.5MG
1MG
2MG
3MG
4MG
N 205422
N 205422
N 205422
N 205422
N 205422
N 205422
001
002
003
004
005
006
Jul
Jul
Jul
Jul
Jul
Jul
AB
AT
AT
AT
AT
AP
AP
BIVALIRUDIN
INJECTABLE;INTRAVENOUS
BIVALIRUDIN
HOSPIRA INC
BOSUTINIB MONOHYDRATE
TABLET;ORAL
BOSULIF
+
WYETH PHARMS INC
BREXPIPRAZOLE
TABLET;ORAL
REXULTI
OTSUKA PHARM CO LTD
May
Jul
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul
05,
20,
20,
20,
20,
10,
10,
10,
10,
10,
10,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
NEWA
NEWA
CTEC
CTEC
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
AT2
AT2
AT1
AT2
AT1
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMDAY
@ BAUSCH AND LOMB INC
+
BROMFENAC SODIUM
APOTEX INC
+
COASTAL PHARMS
HI-TECH PHARMACAL
PADDOCK LLC
2015
EQ 0.09% ACID
EQ 0.09% ACID
N 021664
N 021664
Sep DISC
May CTEC
EQ
EQ
EQ
EQ
A 202620
A 201211
A 203395
A 201941
001
001
001
001
May
May
May
Jan
N 205613
Apr CAHN
A 078949
Mar CTEC
N 203634
Aug CAHN
0.25MG/ML
A 079196
Jun CAHN
0.5MG
0.5MG
1MG
1MG
2MG
2MG
N 018225
N 018225
N 018225
N 018225
N 018225
N 018225
002
002
001
001
003
003
Feb
Feb
Feb
Feb
Jun
Jun
28,
28,
28,
28,
14,
14,
1983
1983
1983
1983
1985
1985
Oct
Oct
Oct
Oct
Oct
Oct
CMFD
CMFD
CMFD
CMFD
CMFD
CMFD
75MCG
150MCG
300MCG
450MCG
600MCG
750MCG
900MCG
N 207932
N 207932
N 207932
N 207932
N 207932
N 207932
N 207932
001
002
003
004
005
006
007
Oct
Oct
Oct
Oct
Oct
Oct
Oct
23,
23,
23,
23,
23,
23,
23,
2015
2015
2015
2015
2015
2015
2015
Oct
Oct
Oct
Oct
Oct
Oct
Oct
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
0.3MG BASE/ML
A 206586
Jul NEWA
2MG
8MG
2MG
8MG
2MG
8MG
A 090819
A 090819
A 201066
A 201066
A 090279
A 090279
001
002
001
002
001
002
Feb
Feb
Mar
Mar
Jun
Jun
19,
19,
06,
06,
10,
10,
2015
2015
2015
2015
2015
2015
Feb
Feb
Feb
Feb
May
May
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
N 022410
N 022410
N 022410
N 022410
001
003
002
004
Aug
Aug
Aug
Aug
30,
10,
30,
10,
2010
2012
2010
2012
Sep
Sep
Sep
Sep
CDFR
CDFR
CDFR
CDFR
A 204431
A 204431
Oct NEWA
Oct NEWA
N 204242
Jun NEWA
ACID
ACID
ACID
ACID
BUDESONIDE
AEROSOL, FOAM;RECTAL
UCERIS
+
VALEANT PHARMS INTL
2MG/ACTUATION
SPRAY, METERED;NASAL
BUDESONIDE
APOTEX INC
0.032MG/INH
TABLET, EXTENDED RELEASE;ORAL
UCERIS
+
VALEANT PHARMS INTL
9MG
AP
>D>
>A> AB
>D>
>A> AB
>D>
>A> AB
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>
BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
EUROHLTH INTL SARL
TABLET;ORAL
BUMEX
@ VALIDUS PHARMS INC
@
@
BUPRENORPHINE HYDROCHLORIDE
FILM;BUCCAL
BELBUCA
ENDO PHARMS INC
AP
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
INJECTABLE;INJECTION
BUPRENORPHINE HYDROCHLORIDE
PAR STERILE PRODUCTS
EQ
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ
EQ
MYLAN PHARMS INC
EQ
EQ
SANDOZ INC
EQ
EQ
BASE
BASE
BASE
BASE
BASE
BASE
1 -13
October
0.09%
0.09%
0.09%
0.09%
10
Jun
May
Jan
Feb
23,
11,
22,
10,
2014
2011
2014
2015
CTEC
CRLD
CTEC
NEWA
AB1
AB1
AB1
AB2
AB
AB
AB
AB
1 -14
October
2015
BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
APLENZIN
VALEANT PHARMS NORTH
174MG
348MG
+
522MG
N 022108
N 022108
N 022108
Feb CAHN
Feb CAHN
Feb CAHN
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
PRINSTON INC
100MG
150MG
200MG
SANDOZ INC
150MG
@ WOCKHARDT LTD
100MG
@
150MG
@
200MG
A 202304
A 202304
A 202304
A 077475
A 201331
A 201331
A 201331
001
002
003
001
001
002
003
May
May
May
Mar
Aug
Aug
Aug
26,
26,
26,
12,
30,
30,
30,
2015
2015
2015
2008
2012
2012
2012
May
May
May
Mar
May
May
May
NEWA
NEWA
NEWA
CAHN
DISC
DISC
DISC
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPIRONE HYDROCHLORIDE
EMCURE PHARMS USA
5MG
10MG
15MG
30MG
A 204582
A 204582
A 204582
A 204582
001
002
003
004
Sep
Sep
Sep
Sep
18,
18,
18,
18,
2015
2015
2015
2015
Sep
Sep
Sep
Sep
NEWA
NEWA
NEWA
NEWA
30MG/5ML
A 085380
001
Jul DISC
50MG
N 000793
003
May DISC
BUTABARBITAL SODIUM
ELIXIR;ORAL
BUTISOL SODIUM
@ MEDA PHARMS
TABLET;ORAL
BUTISOL SODIUM
@ MEDA PHARMS
10
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
BUTOCONAZOLE NITRATE
@ ELAN PHARMA INTL LTD
GYNAZOLE-1
+
PERRIGO ISRAEL
2%
N 019881
May CTNA
2%
A 200923
Jun CTNA
AP
CAFFEINE CITRATE
SOLUTION;INTRAVENOUS
CAFFEINE CITRATE
AUROBINDO PHARMA LTD
Sep NEWA
AB
CALCIPOTRIENE
CREAM;TOPICAL
CALCIPOTRIENE
GLENMARK PHARMS LTD
0.005%
A 205772
May NEWA
200 IU/ML
A 073690
Mar CAHN
100 IU/ML
200 IU/ML
N 017808
N 017808
Aug CAHN
Aug CAHN
AB
CALCITONIN SALMON
INJECTABLE;INJECTION
CALCITONIN-SALMON
@ IGI LABS INC
MIACALCIN
@ MYLAN IRELAND LTD
+
SPRAY, METERED;NASAL
MIACALCIN
+
MYLAN IRELAND LTD
200 IU/SPRAY
N 020313
Aug CAHN
0.25MCG
0.5MCG
0.25MCG
0.5MCG
A 091174
A 091174
A 091356
A 091356
001
002
001
002
Jan
Jan
Jan
Jan
AB
AB
AB
AB
CALCITRIOL
CAPSULE;ORAL
CALCITRIOL
BANNER LIFE SCIENCES
STRIDES PHARMA
May
May
Dec
Dec
24,
24,
12,
12,
2013
2013
2014
2014
CAHN
CAHN
CAHN
CAHN
INJECTABLE;INJECTION
CALCIJEX
@ ABBVIE
@
CALCITRIOL
@ AKORN
@ FRESENIUS KABI USA
@
@ FRESENIUS MEDCL
@
@ LUITPOLD
@
@ SAGENT PHARMS
AB
AB
>A> AB
AB
AB
AB
>A>
>D>
CALCIUM ACETATE
CAPSULE;ORAL
CALCIUM ACETATE
HERITAGE PHARMS INC
LUPIN LTD
NOSTRUM LABS INC
ZYDUS PHARMS USA INC
TABLET;ORAL
CALCIUM ACETATE
HERITAGE PHARMS INC
ZYDUS PHARMS USA INC
>D>
>A>
>D>
>D>
0.001MG/ML
0.002MG/ML
N 018874
N 018874
Jun DISC
Jun DISC
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
A 078066
A 075836
A 075836
A 075766
A 075766
A 075746
A 075746
A 077102
002
001
002
001
002
001
002
001
Jan
Dec
Dec
Feb
Feb
Sep
Sep
Feb
29,
31,
31,
20,
20,
26,
26,
08,
2008
2002
2002
2003
2003
2003
2003
2006
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
DISC
DISC
DISC
DISC
DISC
DISC
DISC
DISC
EQ
EQ
EQ
EQ
CALCIUM
CALCIUM
CALCIUM
CALCIUM
A 202315
A 202127
A 203179
A 202315
001
001
001
001
Jun
Jul
Oct
Jun
29,
09,
26,
29,
2015
2015
2015
2015
Sep
Jun
Oct
Jun
CAHN
NEWA
NEWA
NEWA
EQ 169MG CALCIUM
EQ 169MG CALCIUM
A 202885
A 202885
Sep CAHN
Jan NEWA
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.157GM/1000ML;2.2
1GM/1000ML;7.07GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.157GM/1000ML;2.2
1GM/1000ML;7.07GM/1000ML (5000ML)
Jan CPOT
N 021703
Oct CAHN
N 021703
Oct CAHN
N 021703
Jan CPOT
N 021703
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.314GM/1000ML;2.2
1GM/1000ML;7.07GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.314GM/1000ML;2.2
1GM/1000ML;7.07GM/1000ML (5000ML)
Jan CPOT
Oct CAHN
Oct CAHN
@ BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.157GM/1000ML;
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
@
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.157GM/1000ML;
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
1GM/1000ML;7.07GM/1000ML (5000ML)
+
>A>
2015
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
SODIUM CHLORIDE
INJECTABLE;INJECTION
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
+
BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703 010 Oct 10, 2008
Oct CAHN
L;3.05GM/1000ML;0.157GM/1000ML;2.2
1GM/1000ML;7.07GM/1000ML (5000ML)
>A>
1 -15
October
169MG
169MG
169MG
169MG
10
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
+
GAMBRO RENAL PRODS
3.68GM/1000ML;20GM/1000ML;5.4GM/10 N 021703
00ML;3.05GM/1000ML;0.314GM/1000ML;
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
+
>A>
>D>
>A>
>D>
>A>
>D>
>A>
>D>
>A>
>D>
Oct CAHN
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006
00ML;3.05GM/1000ML;N/A/1000ML;3.09
GM/1000ML;6.46GM/1000ML (5000ML)
Jan CPOT
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006
L;2.03GM/1000ML;0.157GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006
L;2.03GM/1000ML;0.157GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Jan CPOT
N 021703
003 Oct 25, 2006
Oct CAHN
N 021703
003 Oct 25, 2006
Oct CAHN
N 021703
003 Oct 25, 2006
Jan CPOT
N 021703
005 Oct 25, 2006
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
005 Oct 25, 2006
L;3.05GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
005 Oct 25, 2006
L;3.05GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Jan CPOT
BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008
L;2.44GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
GAMBRO RENAL PRODS
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008
L;2.44GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008
L;2.44GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
Jan CPOT
BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
004 Oct 25, 2006
00ML;3.05GM/1000ML;0.314GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
+
GAMBRO RENAL PRODS
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
004 Oct 25, 2006
00ML;3.05GM/1000ML;0.314GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
+
Jan CPOT
Oct CAHN
BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.157GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
+
GAMBRO RENAL PRODS
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.157GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
+
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.157GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
@ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
L;3.05GM/1000ML;0.314GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
+
1 -16
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006
00ML;3.05GM/1000ML;N/A/1000ML;3.09
GM/1000ML;6.46GM/1000ML (5000ML)
BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006
L;2.03GM/1000ML;0.157GM/1000ML;3.0
9GM/1000ML;6.46GM/1000ML (5000ML)
>D>
-
October
2015
INJECTABLE;INJECTION
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
+
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
013 Oct 10, 2008
00ML;3.05GM/1000ML;0.314GM/1000ML;
2.21GM/1000ML;7.07GM/1000ML
(5000ML)
+
BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006
00ML;3.05GM/1000ML;N/A/1000ML;3.09
GM/1000ML;6.46GM/1000ML (5000ML)
>A>
10
Oct CAHN
Oct CAHN
>A>
>D>
>A>
>A>
>D>
>A>
>D>
1 -17
October
2015
N 021703
Jan CPOT
N 021703
Oct CAHN
N 021703
Oct CAHN
N 021703
Jan CPOT
N 021703
Oct CAHN
N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;3.05GM/1000ML;N/A/1000ML;3.09GM/1
000ML;6.46GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;3.05GM/1000ML;N/A/1000ML;3.09GM/1
000ML;6.46GM/1000ML (5000ML)
Jan CPOT
Oct CAHN
N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;2.44GM/1000ML;N/A/1000ML;3.09GM/1
000ML;6.46GM/1000ML (5000ML)
Oct CAHN
N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;2.44GM/1000ML;N/A/1000ML;3.09GM/1
000ML;6.46GM/1000ML (5000ML)
Jan CPOT
Oct CAHN
5.15GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;2.03GM/1000ML;N/A/1000ML;3.09G
M/1000ML;6.46GM/1000ML (5000ML)
Oct CAHN
5.15GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;2.03GM/1000ML;N/A/1000ML;3.09G
M/1000ML;6.46GM/1000ML (5000ML)
Jan CPOT
Oct CAHN
Oct CAHN
Jan CPOT
000ML;6.46GM/1000ML (5000ML)
GAMBRO RENAL PRODS
>D>
INJECTABLE;INJECTION
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
+
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.314GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
@ BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.314GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
@
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.314GM/1000ML;
3.09GM/1000ML;6.46GM/1000ML
(5000ML)
@ BAXTER HLTHCARE
N/A/1000ML;N/A/1000ML;5.4GM/1000ML
;3.05GM/1000ML;N/A/1000ML;3.09GM/1
000ML;6.46GM/1000ML (5000ML)
>D>
>A>
10
M/1000ML;6.46GM/1000ML (5000ML)
GAMBRO RENAL PRODS
@ BAXTER HLTHCARE
3.68GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;3.05GM/1000ML;0.314GM/1000ML;3
.09GM/1000ML;6.46GM/1000ML
(5000ML)
.09GM/1000ML;6.46GM/1000ML
(5000ML)
@
3.68GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;3.05GM/1000ML;0.314GM/1000ML;3
.09GM/1000ML;6.46GM/1000ML
(5000ML)
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
/1000ML;6.95GM/1000ML;0.187GM/1000
ML (5000ML)
10
October
INJECTABLE;INJECTION
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
+
GAMBRO LUNDIA
3.68GM/1000ML;N/A/1000ML;N/A/1000M N 207026
L;3.05GM/1000ML;0.314GM/1000ML
;3.09GM/1000ML;6.34GM/1000ML;0.187
GM/1000ML (5000ML)
1 -18
2015
Jan NEWA
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
L;0.42MG/ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;
SODIUM LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
37MG/100ML;5GM/100ML;30MG/100ML;11 N 017390 001
Mar DISC
9MG/100ML;161MG/100ML;94MG/100ML;1
38MG/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE R IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
36.8MG/100ML;30.5MG/100ML;74.6MG/1 N 017438 001
Mar DISC
00ML;640MG/100ML;496MG/100ML;89.6M
G/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
PHOSPHATE
INJECTABLE;INJECTION
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
+
BAXTER HLTHCARE
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;
0.187GM/1000ML (5000ML)
+
GAMBRO LUNDIA
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;
0.187GM/1000ML (5000ML)
+
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;
0.187GM/1000ML (5000ML)
+
BAXTER HLTHCARE
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML
;3.09GM/1000ML;6.34GM/1000ML;0.187
+
GAMBRO LUNDIA
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML
;3.09GM/1000ML;6.34GM/1000ML;0.187
+
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML
;3.09GM/1000ML;6.34GM/1000ML;0.187
>A>
>D>
>A>
>D>
Oct CAHN
Oct CAHN
Feb CAIN
Oct CAHN
Oct CAHN
Feb CAIN
Sep DISC
A 204100
A 204100
A 204100
Feb NEWA
Feb NEWA
Feb NEWA
A 202593
A 202593
Apr NEWA
Apr NEWA
AB
AB
CAPECITABINE
TABLET;ORAL
CAPECITABINE
ACCORD HLTHCARE
150MG
500MG
10
1 -19
October
2015
A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074434
001
001
001
004
002
002
002
002
003
003
003
001
004
004
004
003
004
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
May
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CRLD
Dec
Dec
Dec
Dec
29,
29,
29,
29,
1997
1997
1997
1997
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
AB
CAPTOPRIL
TABLET;ORAL
CAPTOPRIL
@ G AND W LABS INC
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
+
MYLAN
AB
AB
AB
AB
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
G AND W LABS INC
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
A 074827
A 074827
A 074827
A 074827
001
002
004
003
AB
AB
AB
CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
MYLAN PHARMS INC
100MG
200MG
300MG
A 076697
A 076697
A 076697
May CAHN
May CAHN
May CAHN
N 203312
N 203312
N 203312
N 203312
001
002
003
004
Jan
Jan
Jan
Jan
N 203952
Jan NEWA
N 204370
N 204370
N 204370
N 204370
001
002
003
004
Sep
Sep
Sep
Sep
17,
17,
17,
17,
2015
2015
2015
2015
Sep
Sep
Sep
Sep
NEWA
NEWA
NEWA
NEWA
250MG
350MG
250MG
350MG
A 205126
A 205126
A 205513
A 205513
001
002
001
002
Jul
Jul
Nov
Nov
08,
08,
12,
12,
2015
2015
2015
2015
Jun
Jun
Oct
Oct
NEWA
NEWA
NEWA
NEWA
250MG
N 011792
Jun CTEC
3.125MG
6.25MG
12.5MG
A 077887
A 077887
A 077887
Jun DISC
Jun DISC
Jun DISC
12.5MG
12.5MG
12.5MG
12.5MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
100MG
100MG
100MG
100MG
100MG
CARBIDOPA; LEVODOPA
CAPSULE, EXTENDED RELEASE;ORAL
RYTARY
IMPAX LABS INC
23.75MG;95MG
36.25MG;145MG
48.75MG;195MG
+
61.25MG;245MG
SUSPENSION;ENTERAL
DUOPA
+
ABBVIE INC
4.63MG/ML;20MG/ML
CARIPRAZINE HYDROCHLORIDE
CAPSULE;ORAL
VRAYLAR
FOREST RES INST INC
AB
AA
>A> AB
>A> AA
AB
CARISOPRODOL
TABLET;ORAL
CARISOPRODOL
INDICUS PHARMA
SHASUN PHARMS LTD
SOMA
MEDA PHARMS
CARVEDILOL
TABLET;ORAL
CARVEDILOL
@ HIKMA
@
@
EQ
EQ
EQ
EQ
1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE
Jan
Jan
Jan
Jan
07,
07,
07,
07,
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
AB
AB
AB
AB
AB
AB
AP
AP
AP
AP
AB
AB
AB
AB
TABLET;ORAL
CARVEDILOL
@
SUN PHARM INDS LTD
2015
A 077887
A 076989
A 076989
A 076989
A 076989
004
001
002
003
004
A 065115
A 065115
A 065115
Apr CAHN
Apr CAHN
Apr CAHN
A 063214
A 063207
A 063209
A 063209
001
001
001
002
Jan
Jan
Jan
Jan
N 207131
Sep CAHN
N 207131
Aug NEWA
100MG/5ML
200MG/5ML
A 204835
A 204835
Apr NEWA
Apr NEWA
100MG/5ML
200MG/5ML
A 065129
A 065355
Apr CFTG
Apr CFTG
A 063293
N 050588
A 063293
N 050588
N 050588
001
001
002
002
003
May
Mar
May
Mar
Mar
N 050694
N 050694
Mar CAHN
Mar CAHN
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
A 065082
A 065082
Apr CAHN
Apr CAHN
EQ 100MG BASE
EQ 200MG BASE
A 065083
A 065083
Apr CAHN
Apr CAHN
500MG/VIAL
500MG/VIAL
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
6GM/VIAL
500MG/VIAL
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
001
001
002
002
003
003
004
004
001
Oct
Jun
Oct
Jun
Oct
Jun
Oct
Jun
Oct
CEFADROXIL/CEFADROXIL HEMIHYDRATE
FOR SUSPENSION;ORAL
CEFADROXIL
SUN PHARM INDS LTD
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
FACTA FARMA
EQ
EQ
EQ
EQ
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL
+
SOLUTION;INTRAVENOUS
CEFAZOLIN IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 2GM BASE/100ML (EQ 20MG
BASE/ML)
CELERITY PHARMS
EQ 2GM BASE/100ML (EQ 20MG
BASE/ML)
CEFIXIME
FOR SUSPENSION;ORAL
CEFIXIME
AUROBINDO PHARMA LTD
SUPRAX
LUPIN PHARMS
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTAN
@ IGI LABS INC
EQ 1GM BASE/VIAL
@
EQ 1GM BASE/VIAL
@
EQ 2GM BASE/VIAL
@
EQ 2GM BASE/VIAL
@
EQ 10GM BASE/VIAL
CEFOTAN IN PLASTIC CONTAINER
@ IGI LABS INC
EQ 20MG BASE/ML
@
EQ 40MG BASE/ML
AB
AB
AB
AB
>D> AP
AP
>D> AP
AP
>D> AP
AP
>D> AP
AP
>A> AP
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
CEFPODOXIME PROXETIL
SUN PHARM INDS LTD
TABLET;ORAL
CEFPODOXIME PROXETIL
SUN PHARM INDS LTD
CEFTAZIDIME
INJECTABLE;INJECTION
FORTAZ
+
CONCORDIA PHARMS INC
+
+
+
+
+
+
+
+
IGI LABS INC
1 -20
October
25MG
3.125MG
6.25MG
12.5MG
25MG
10
Sep
Sep
Sep
Sep
Sep
Dec
Dec
Dec
Apr
Apr
Dec
Apr
Dec
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
07,
05,
05,
05,
05,
27,
27,
27,
30,
29,
27,
29,
27,
25,
19,
19,
19,
19,
19,
19,
19,
19,
19,
2007
2007
2007
2007
2007
1991
1991
1991
1999
1993
1985
1993
1985
1988
1985
1985
1985
1985
1985
1985
1985
1985
1985
Jun
Apr
Apr
Apr
Apr
DISC
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
>A> AP
>A> AP
>A> AP
2015
N 050578
N 050578
N 050578
Oct CAHN
Oct CAHN
Oct CAHN
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
001
001
002
002
003
003
001
002
003
Oct
Jun
Oct
Jun
Oct
Jun
Oct
Oct
Oct
N 206829
Aug CAHN
A 065269
Jan CAHN
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
A 065268
A 065268
A 065245
Jan CAHN
Jan CAHN
Jul DISC
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
A 065323
A 065323
Apr CAHN
Apr CAHN
EQ
EQ
EQ
EQ
EQ
A 065190
A 065190
A 065118
A 065118
A 065118
001
002
001
002
003
Jul
Jul
Apr
Apr
Apr
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
A 064125
A 064124
Jan CAHN
Jan CAHN
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
ZINACEF IN PLASTIC CONTAINER
@ CONCORDIA PHARMS INC
EQ 15MG BASE/ML
+
EQ 30MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
FACTA FARMA
EQ 750MG BASE/VIAL
ZINACEF
+
CONCORDIA PHARMS INC EQ 750MG BASE/VIAL
N 050558
N 050558
Jun CAHN
Jun CAHN
N 050643
N 050643
Jun CAHN
Jun CAHN
A 064125
Jan CAHN
N 050558
Jun CAHN
A 204519
A 204519
A 204519
A 204519
001
002
003
004
Aug
Aug
Aug
Aug
1GM/VIAL
2GM/VIAL
6GM/VIAL
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
FORTAZ IN PLASTIC CONTAINER
@ CONCORDIA PHARMS INC EQ
@
EQ
+
EQ
+
EQ
+
EQ
+
EQ
@ IGI LABS INC
EQ
+
EQ
+
EQ
>D>
>D>
>D>
>A>
>A>
>A>
10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
AP
AB
AB
AB
AB
AB
AB
AB
AP
AP
AP
AP
AB
AB
AB
AB
AB
AB
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
FACTA FARMA
INJECTABLE;INTRAMUSCULAR,
CEFTRIAXONE
@ FACTA FARMA
@
@ FRESENIUS KABI USA
CEFUROXIME AXETIL
FOR SUSPENSION;ORAL
CEFUROXIME AXETIL
SUN PHARM INDS LTD
TABLET;ORAL
CEFUROXIME AXETIL
ANI PHARMS INC
SUN PHARM INDS LTD
CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
FACTA FARMA
+
+
EQ 10GM BASE/VIAL
INTRAVENOUS
250MG
500MG
125MG
250MG
500MG
ZINACEF
CONCORDIA PHARMS INC
CELECOXIB
CAPSULE;ORAL
CELECOXIB
ALEMBIC PHARMS LTD
50MG
100MG
200MG
400MG
BASE
BASE
BASE
BASE
BASE
1 -21
October
INJECTABLE;INJECTION
FORTAZ
+
+
+
10
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Oct
Oct
Apr
Apr
Apr
Aug
Aug
Aug
Aug
28,
28,
28,
28,
28,
28,
28,
28,
28,
18,
18,
25,
25,
25,
21,
21,
21,
21,
1989
1989
1989
1989
1989
1989
1989
1989
1989
2004
2004
2003
2003
2003
2015
2015
2015
2015
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
NEWA
2015
50MG
100MG
200MG
50MG
100MG
200MG
400MG
100MG
200MG
400MG
100MG
200MG
400MG
50MG
100MG
200MG
400MG
A 204197
A 204197
A 204197
A 207446
A 207446
A 207446
A 207446
A 202240
A 202240
A 202240
A 078857
A 078857
A 078857
A 200562
A 200562
A 200562
A 200562
001
002
003
001
002
003
004
002
003
004
002
003
004
001
002
003
004
EQ 250MG BASE
EQ 500MG BASE
A 065007
A 065007
Apr CAHN
Apr CAHN
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
A 065081
A 065081
Apr CAHN
Apr CAHN
AA
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
ZYRTEC
+
J AND J CONSUMER INC
5MG/5ML
N 020346
Aug CAHN
AP
CHLOROTHIAZIDE SODIUM
INJECTABLE;INJECTION
CHLOROTHIAZIDE SODIUM
SAGENT PHARMS
EQ 500MG BASE/VIAL
A 202462
May NEWA
N 206323
Jun NEWA
A 206438
Jan NEWA
N 204307
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
CIPLA LTD
LUPIN LTD
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
SUN PHARM INDS LTD
FOR SUSPENSION;ORAL
CEPHALEXIN
@ SUN PHARM INDS LTD
@
1 -22
October
CAPSULE;ORAL
CELECOXIB
APOTEX INC
10
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Jun
Jun
Jun
Feb
Feb
Feb
Feb
Feb
Feb
Feb
02,
02,
02,
23,
23,
23,
23,
09,
09,
09,
11,
11,
11,
11,
11,
11,
11,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
May
May
May
Sep
Sep
Sep
Sep
May
May
May
Jan
Jan
Jan
Jan
Jan
Jan
Jan
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
AA
Jan CFTG
AA
Jul NEWA
AA
+
VERNALIS R AND D LTD
EQ 2.8MG BASE/5ML;EQ 14.7MG
BASE/5ML
CHLORPROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
@ CYCLE PHARMS LTD
30MG/ML
@
100MG/ML
N 207768
Apr NEWA
N 207768
Jun CAHN
A 088157
A 088158
Jun CAHN
Jun CAHN
October
2015
1 -23
A 083329
001
Feb CAHN
A 085331
A 085331
A 085331
A 085331
A 085331
A 080439
A 080439
A 080439
A 080439
A 080439
001
002
003
004
005
001
002
003
004
005
Jun
Jun
Jun
Jun
Jun
May
May
May
May
May
50MG
50MG
50MG
A 088651
A 089286
A 086831
Apr CAHN
Mar CMFD
Jun CTEC
15MG
N 019574
Jun DISC
CHOLESTYRAMINE
POWDER;ORAL
CHOLESTYRAMINE
@ ANI PHARMS INC
@
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
A 074554
A 074554
Aug CAHN
Aug CAHN
CHOLIC ACID
CAPSULE;ORAL
CHOLBAM
ASKLEPION PHARMS LLC
+
RTRX
+
50MG
250MG
50MG
250MG
N 205750
N 205750
N 205750
N 205750
001
002
001
002
Mar
Mar
Apr
Apr
CHOLINE C-11
INJECTABLE;INTRAVENOUS
CHOLINE C-11
+
MCPRF
+
UNIV TX MD ANDERSON
4-33.1mCi/ML
4-33.1mCi/ML
4-33.1mCi/ML
N 203155
N 203155
A 205690
Oct CFTG
Oct CFTG
Oct NEWA
AB
AB
CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE;ORAL
FENOFIBRIC ACID
ACTAVIS ELIZABETH
EQ 45MG FENOFIBRIC ACID
EQ 135MG FENOFIBRIC ACID
A 200920
A 200920
Sep NEWA
Sep NEWA
AT
CICLOPIROX
SOLUTION;TOPICAL
CICLOPIROX
APOTEX INC
8%
A 078172
Sep CMFD
AP
CIDOFOVIR
INJECTABLE;INJECTION
CIDOFOVIR
+
MYLAN INSTITUTIONAL
EQ 75MG BASE/ML
A 201276
May CRLD
A 074176
Apr CAHN
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
+
EUROHLTH INTL SARL
25MG/ML
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
@ CYCLE PHARMS LTD
10MG
@
25MG
@
50MG
@
100MG
@
200MG
@ SANDOZ
10MG
@
25MG
@
50MG
@
100MG
@
200MG
AB
AB
>D>
>A> AP
>A> AP
CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
@ G AND W LABS INC
MUTUAL PHARM
+
MYLAN
THALITONE
@ CITRON PHARMA LLC
CIMETIDINE HYDROCHLORIDE
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
@ G AND W LABS INC
EQ 300MG BASE/5ML
10
Mar
Mar
Mar
Mar
17,
17,
17,
17,
2015
2015
2015
2015
CAHN
CAHN
CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC
DISC
NEWA
NEWA
CAHN
CAHN
AP
AP
AP
AP
>D> AT
>A> AT
AB
AB
AB
2015
A 078062
A 078062
Apr CAHN
Apr CAHN
A 078024
A 078024
Apr CAHN
Apr CAHN
0.3% BASE
0.3% BASE
A 077689
A 077689
Oct CAHN
Oct CAHN
250MG BASE
500MG BASE
750MG BASE
A 075747
A 075747
A 075747
Apr CAHN
Apr CAHN
Apr CAHN
A 203183
Feb NEWA
A 203182
A 203182
Feb NEWA
Feb NEWA
A 206774
Aug NEWA
A 077048
A 077048
A 077048
Apr CAHN
Apr CAHN
Apr CAHN
A 065382
A 065382
Apr CAHN
Apr CAHN
A 203584
A 203584
A 065174
A 065174
001
002
001
002
Sep
Sep
Apr
Apr
A 202532
A 065154
Aug NEWA
Jan CRLD
A 062691
May DISC
N 050590
May DISC
N 050590
May DISC
N 050590
May DISC
N 050658
May DISC
CIPROFLOXACIN
INJECTABLE;INJECTION
CIPROFLOXACIN
CLARIS PHARMASERVICE
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
CLARIS PHARMASERVICE 200MG/100ML
400MG/200ML
CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
NEXUS PHARMS
EQ
RISING PHARMS INC
EQ
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
SUN PHARM INDS LTD
EQ
EQ
EQ
AP
AP
AP
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
ACCORD HLTHCARE
AB
AB
AB
CITALOPRAM HYDROBROMIDE
TABLET;ORAL
CITALOPRAM HYDROBROMIDE
G AND W LABS INC
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
AB
AB
AB
AB
AB
AB
AB
AB
CLARITHROMYCIN
FOR SUSPENSION;ORAL
CLARITHROMYCIN
SUN PHARM INDS LTD
1 -24
October
CISATRACURIUM BESYLATE
INJECTABLE;INJECTION
CISATRACURIUM BESYLATE
FRESENIUS KABI USA
EQ 2MG BASE/ML
CISATRACURIUM BESYLATE PRESERVATIVE FREE
FRESENIUS KABI USA
EQ 2MG BASE/ML
EQ 10MG BASE/ML
AP
10
1MG/ML
125MG/5ML
250MG/5ML
TABLET;ORAL
CLARITHROMYCIN
HEC PHARM USA INC
250MG
500MG
SUN PHARM INDS LTD
250MG
500MG
TABLET, EXTENDED RELEASE;ORAL
CLARITHROMYCIN
LUPIN LTD
500MG
+
TEVA
500MG
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TIMENTIN
@ GLAXOSMITHKLINE
EQ 100MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 100MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 200MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL
TIMENTIN IN PLASTIC CONTAINER
@ GLAXOSMITHKLINE
EQ 100MG BASE/100ML;EQ 3GM
BASE/100ML
Sep
Sep
Sep
Sep
28,
28,
24,
24,
2015
2015
2004
2004
NEWA
NEWA
CAHN
CAHN
CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
@ ANI PHARMS INC
AB
AB
AB
AB
AP
AP
AP
AT
AB
AB
1.34MG
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLINDAMYCIN HYDROCHLORIDE
G AND W LABS INC
EQ
EQ
SUN PHARM INDS LTD
EQ
EQ
CLINDAMYCIN PHOSPHATE
INJECTABLE;INJECTION
CLINDAMYCIN PHOSPHATE
ALVOGEN INC
EQ
EQ
EQ
EQ
1 -25
October
2015
A 073282
Jul CAHN
BASE
BASE
BASE
BASE
A 063029
A 063029
A 065061
A 065061
001
002
001
002
Sep
Aug
Feb
Feb
20,
05,
02,
02,
1989
2005
2001
2001
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
150MG
150MG
150MG
150MG
BASE/ML
BASE/ML
BASE/ML
BASE/ML
A 062800
A 062801
A 062943
A 062928
001
001
001
001
Jul
Jul
Sep
Feb
24,
24,
29,
13,
1987
1987
1988
1989
Sep
Sep
Sep
Mar
CAHN
CAHN
CAHN
CAHN
A 062944
A 203343
Jan CAHN
May NEWA
A 202564
Jun NEWA
N 050802
Jun CTEC
A 075430
May CRLD
A 074220
Jun CRLD
A 075368
May CRLD
A 074089
Feb CAHN
A 074331
Mar CMFD
N 018361
Jun DISC
A 090873
A 090873
A 090873
Mar CAHN
Mar CAHN
Mar CAHN
A 071783
A 071784
A 071785
May DISC
May DISC
May DISC
A 202792
A 203320
May NEWA
May NEWA
EQ 1% BASE
EQ 1% BASE
CLOBETASOL PROPIONATE
CREAM;TOPICAL
CLOBETASOL PROPIONATE (EMOLLIENT)
AB2
+
FOUGERA PHARMS
0.05%
CORMAX
AB1
+
HI TECH PHARMA
0.05%
GEL;TOPICAL
CLOBETASOL PROPIONATE
AB
+
FOUGERA PHARMS
0.05%
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
AB
G AND W LABS INC
0.05%
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
AT
G AND W LABS INC
0.05%
AB
AB
AB
150MG
300MG
150MG
300MG
CLOMIPHENE CITRATE
TABLET;ORAL
SEROPHENE
@ EMD SERONO
10
50MG
CLONIDINE
FILM, EXTENDED RELEASE;TRANSDERMAL
CLONIDINE
ACTAVIS LABS UT INC
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
@ DAVA PHARMS INC
0.1MG
@
0.2MG
@
0.3MG
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AB2
ACTAVIS ELIZABETH
0.1MG
AB1
0.1MG
AB2
AB1
AB2
AB2
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
October
2015
A 202792
A 202792
A 203320
A 203320
A 202983
A 202983
A 202983
A 202983
002
002
002
002
001
001
002
002
1 -26
A 202984
A 202984
A 202984
May CTEC
Aug DISC
May CTEC
N 022331
N 022331
N 022331
N 022331
N 022331
N 022331
003
003
003
004
004
004
Aug
Jun
May
Aug
Jun
May
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
SUN PHARM INDS LTD
3.75MG
7.5MG
15MG
A 076911
A 076911
A 076911
Apr CAHN
Apr CAHN
Apr CAHN
A 203807
A 203807
Sep NEWA
Sep NEWA
N 019758
N 019758
Aug CAHN
Aug CAHN
A 201824
A 201824
Aug NEWA
Aug NEWA
N 021590
N 021590
Aug CFTG
Aug CFTG
N 205395
Jan NEWA
AMNEAL PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML
A 200963 001 Aug 26, 2015
Aug NEWA
CODEINE SULFATE
SOLUTION;ORAL
CODEINE SULFATE
@ ROXANE
30MG/5ML
N 202245
Jan DISC
COLCHICINE
CAPSULE;ORAL
MITIGARE
HIKMA INTL PHARMS
0.6MG
N 204820
Jan CAHN
A 083734
001
Aug CAHN
CLOZAPINE
TABLET;ORAL
CLOZAPINE
ACTAVIS LABS FL INC
25MG
100MG
CLOZARIL
HERITAGE LIFE
25MG
+
100MG
TABLET, ORALLY DISINTEGRATING;ORAL
CLOZAPINE
MYLAN PHARMS INC
25MG
100MG
FAZACLO ODT
JAZZ PHARMS III
25MG
+
100MG
COBICISTAT; DARUNAVIR ETHANOLATE
TABLET;ORAL
PREZCOBIX
+
JANSSEN PRODS
150MG;EQ 800MG BASE
AA
10
COLCHICINE; PROBENECID
TABLET;ORAL
PROBENECID AND COLCHICINE
@ ANI PHARMS INC
0.5MG;500MG
May
May
May
May
Apr
Apr
Apr
Apr
Sep
Sep
Sep
Sep
Sep
Sep
15,
15,
15,
15,
02,
02,
02,
02,
28,
28,
28,
28,
28,
28,
2015
2015
2015
2015
2014
2014
2014
2014
2010
2010
2010
2010
2010
2010
Aug
May
Aug
May
Aug
May
Aug
May
DISC
NEWA
DISC
NEWA
DISC
CTEC
DISC
CTEC
CRLD
CRLD
CTEC
DISC
CRLD
CTEC
10
October
2015
1 -27
COLISTIMETHATE SODIUM
INJECTABLE;INJECTION
COLISTIMETHATE SODIUM
XELLIA PHARMS APS
EQ 150MG BASE/VIAL
A 205356
May NEWA
CORTICOTROPIN
INJECTABLE;INJECTION
H.P. ACTHAR GEL
@ MALLINCKRODT ARD
+
40 UNITS/ML
80 UNITS/ML
N 008372
N 008372
006
008
Aug CAHN
Aug CAHN
CYANOCOBALAMIN
INJECTABLE;INJECTION
CYANOCOBALAMIN
@ EUROHLTH INTL SARL
1MG/ML
A 080515
002
Feb CAHN
AB
AB
AB
AB
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
ORIT LABS LLC
5MG
SUN PHARM INDS LTD
5MG
7.5MG
10MG
A 078218
A 078722
A 078722
A 078722
002
001
002
003
AA
CYPROHEPTADINE HYDROCHLORIDE
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
MIRROR PHARMS LLC
4MG
A 205087
Sep NEWA
DABRAFENIB MESYLATE
CAPSULE;ORAL
TAFINLAR
NOVARTIS PHARMS CORP
+
EQ 50MG BASE
EQ 75MG BASE
N 202806
N 202806
Mar CAHN
Mar CAHN
DACLATASVIR DIHYDROCHLORIDE
TABLET;ORAL
DAKLINZA
BRISTOL-MYERS SQUIBB
+
EQ 30MG BASE
EQ 60MG BASE
N 206843
N 206843
Jul NEWA
Jul NEWA
7,500 IU/0.75ML
7,500 IU/0.75ML
N 020287
N 020287
Jun CAHN
Apr CAHN
2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/0.4ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)
2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/0.4ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
001
003
005
002
004
009
010
011
006
007
001
003
005
002
004
009
010
011
006
007
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
AP
DALTEPARIN SODIUM
INJECTABLE;INJECTION
FRAGMIN
@ PFIZER INC
@ PHARMACIA AND UPJOHN
INJECTABLE;SUBCUTANEOUS
FRAGMIN
PFIZER INC
+
@
PHARMACIA AND UPJOHN
+
@
Jun
May
May
May
Dec
Mar
Apr
May
Jan
May
May
May
Apr
Apr
Dec
Mar
Apr
May
Jan
May
May
May
Apr
Apr
19,
12,
12,
12,
22,
18,
04,
01,
30,
01,
01,
01,
04,
04,
22,
18,
04,
01,
30,
01,
01,
01,
04,
04,
2015
2008
2008
2008
1994
1996
2002
2007
1998
2007
2007
2007
2002
2002
1994
1996
2002
2007
1998
2007
2007
2007
2002
2002
Jun
Apr
Apr
Apr
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
AB
AB
AB
AB
2015
A 076686
A 076686
A 076686
May CAHN
May CAHN
May CAHN
7.5MG BASE
15MG BASE
A 091190
A 091190
Mar NEWA
Mar NEWA
7.5MG BASE
15MG BASE
N 021513
N 021513
Mar CFTG
Mar CFTG
100MG
140MG
N 021986
N 021986
Sep CRLD
Sep CRLD
50MG/VIAL
N 021790
Jan CAHN
90MG
180MG
360MG
N 206910
N 206910
N 206910
Mar NEWA
Mar NEWA
Mar NEWA
100MG/ML
N 208030
Sep NEWA
DEMECLOCYCLINE HYDROCHLORIDE
TABLET;ORAL
DEMECLOCYCLINE HYDROCHLORIDE
EPIC PHARMA LLC
150MG
300MG
A 065447
A 065447
Aug NEWA
Aug NEWA
DEOXYCHOLIC ACID
SOLUTION;SUBCUTANEOUS
KYBELLA
+
KYTHERA BIOPHARMS
N 206333
Apr NEWA
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
ANI PHARMS INC
25MG
50MG
75MG
150MG
A 071803
A 071803
A 071803
A 071803
002
003
004
005
Sep
Sep
Sep
Sep
DESIRUDIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPRIVASK
+
VALEANT PHARMS NORTH
15MG/VIAL
N 021271
May CAHN
0.5MG/ML
N 021300
Jun CFTG
0.5MG/ML
A 202592
Jun NEWA
DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
DARIFENACIN HYDROBROMIDE
ANCHEN PHARMS
EQ
EQ
ENABLEX
WARNER CHILCOTT LLC
EQ
+
EQ
DASATINIB
TABLET;ORAL
SPRYCEL
+
BRISTOL MYERS SQUIBB
AP
DECITABINE
INJECTABLE;INTRAVENOUS
DACOGEN
+
OTSUKA PHARM CO LTD
DEFERASIROX
TABLET;ORAL
JADENU
NOVARTIS PHARMS CORP
+
DEFERIPRONE
SOLUTION;ORAL
FERRIPROX
+
APOPHARMA INC
AB
AB
AA
AA
25MG
50MG
100MG
DESLORATADINE
SOLUTION;ORAL
CLARINEX
+
MERCK SHARP DOHME
DESLORATADINE
TARO PHARM INDS
20MG/2ML (10MG/ML)
1 -28
October
DANTROLENE SODIUM
CAPSULE;ORAL
DANTROLENE SODIUM
ELITE LABS INC
10
Dec
Dec
Dec
May
08,
08,
08,
29,
1987
1987
1987
1997
CMS1
CMS1
CMS1
CMS1
AB
AB
AB
AB
DESMOPRESSIN ACETATE
TABLET;ORAL
DDAVP
FERRING PHARMS INC
+
DESMOPRESSIN ACETATE
GLENMARK PHARMS LTD
10
2015
0.1MG
0.2MG
N 019955
N 019955
Jan CAHN
Jan CAHN
0.1MG
0.2MG
A 201831
A 201831
May NEWA
May NEWA
A 202226
Jul NEWA
N 021090
Aug CAHN
A 202789
Jul NEWA
A 075863
Apr CTEC
A 076681
Apr NEWA
0.05%
A 074027
May CMFD
0.25%
0.25%
A 205082
A 203234
Aug NEWA
Jun NEWA
0.25%
A 077770
Apr NEWA
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
A 204003
A 204003
A 204172
A 204172
A 204095
A 204095
A 204028
A 204028
001
002
001
002
001
002
001
002
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
50MG BASE
100MG BASE
N 021992
N 021992
Jun CFTG
Jun CFTG
A 203129
A 084282
A 087702
Sep NEWA
Mar CAHN
Feb CAHN
N 050065
002
Mar CAHN
N 050023
002
Mar CAHN
AB
AB
DESONIDE
CREAM;TOPICAL
DESONIDE
TEVA PHARMS
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AP
AT
AT
DESOXIMETASONE
CREAM;TOPICAL
DESOXIMETASONE
ACTAVIS MID ATLANTIC
VERSAPHARM INC
OINTMENT;TOPICAL
DESOXIMETASONE
PERRIGO NEW YORK
1 -29
October
DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE SUCCINATE
ALEMBIC PHARMS LTD
EQ
EQ
LUPIN LTD
EQ
EQ
MYLAN PHARMS INC
EQ
EQ
SANDOZ INC
EQ
EQ
PRISTIQ
+
WYETH PHARMS INC
EQ
+
EQ
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
29,
29,
29,
29,
29,
29,
29,
29,
2015
2015
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
AP
AP
>A>
>A>
>A>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
10
DEXMEDETOMIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEXMEDETOMIDINE HYDROCHLORIDE
FRESENIUS KABI USA
EQ 200MCG BASE/2ML (EQ 100MCG
BASE/ML)
PRECEDEX
HOSPIRA
EQ 80MCG BASE/20ML (EQ 4MCG
BASE/ML)
SOLUTION;IV (INFUSION)
DEXMEDETOMIDINE HYDROCHLORIDE
+
HQ SPCLT PHARMA
EQ 1MG BASE/10ML (EQ 100MCG
BASE/ML)
1 -30
October
2015
A 201072
Sep NEWA
A 202126
Aug NEWA
N 021038
Jan NEWA
N 206628
Oct NEWA
N 206628
Oct NEWA
A 204266
A 204266
A 204266
A 204266
A 079108
A 079108
001
002
003
007
001
002
Aug
Aug
Aug
Aug
Jul
Jul
A 201231
A 201231
A 201231
Aug
Aug
Aug
Aug
Aug
Aug
25,
25,
25,
25,
05,
05,
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
Sep NEWA
Sep NEWA
Sep NEWA
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE;INJECTION
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
5GM/100ML;30MG/100ML;37MG/100ML;36 N 017451 001
Mar DISC
8MG/100ML;526MG/100ML;502MG/100ML
AP
AA
AT
AT
>D> AB
>A> AB
AA
50MG
DICLOFENAC SODIUM
GEL;TOPICAL
VOLTAREN
+
GLAXOSMITHKLINE CONS
1%
SOLUTION;TOPICAL
DICLOFENAC SODIUM
IGI LABS INC
1.5%
LUPIN LTD
1.5%
TABLET, EXTENDED RELEASE;ORAL
DICLOFENAC SODIUM
VALEANT INTL
100MG
VPNA
100MG
DIETHYLPROPION HYDROCHLORIDE
TABLET;ORAL
TENUATE
+
ACTAVIS LABS UT INC
25MG
N 019292
Feb CAHN
A 087388
001
Jan CAHN
N 011366
Aug NEWA
N 022122
Aug CAHN
A 202769
A 204132
Jun NEWA
Aug NEWA
A 075492
A 075492
Oct CAHN
Oct CAHN
N 011722
002
Mar CAHN
AB
October
2015
1 -31
N 012546
001
Mar CAHN
AB
DIFLORASONE DIACETATE
OINTMENT;TOPICAL
DIFLORASONE DIACETATE
VERSAPHARM INC
0.05%
A 206572
Jul NEWA
AB
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
HERITAGE PHARMA
500MG
A 202845
Mar CAHN
0.25MG/ML
A 083391
001
Feb CAHN
0.125MG
0.25MG
0.125MG
0.25MG
A 040282
A 040282
A 076363
A 076363
001
002
001
002
Dec
Dec
Jan
Jan
23,
23,
31,
31,
1999
1999
2003
2003
Jan
Jan
Feb
Feb
CTEC
CTEC
CMFD
CMFD
0.0625MG
0.125MG
0.1875MG
0.25MG
0.375MG
0.5MG
N 020405
N 020405
N 020405
N 020405
N 020405
N 020405
001
002
003
004
005
006
Sep
Sep
Sep
Sep
Sep
Sep
30,
30,
30,
30,
30,
30,
1997
1997
1997
1997
1997
1997
Apr
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
A 076151
A 076151
A 076151
A 076151
A 076151
A 076151
A 076151
A 076151
001
001
002
002
003
003
004
004
May
May
May
May
May
May
May
May
20,
20,
20,
20,
20,
20,
20,
20,
2004
2004
2004
2004
2004
2004
2004
2004
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
DISC
DISC
DISC
DISC
DISC
DISC
DISC
DISC
A 075124
Feb CRLD
N 020401
N 020401
N 020401
N 020401
N 020401
N 020401
001
002
003
004
005
006
Feb
Feb
Feb
Feb
Feb
Feb
A 078538
Jun CAHN
AP
AB
AB
AB
AB
DIGOXIN
INJECTABLE;INJECTION
DIGOXIN
EUROHLTH INTL SARL
TABLET;ORAL
DIGOXIN
MYLAN PHARMS INC
SUN PHARM INDS INC
LANOXIN
CONCORDIA PHARMS INC
AB
AB
+
@
@
>D>
>D>
>A>
>D>
>A>
>D>
>A>
>D>
>A>
10
AP
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DILT-CD
APOTEX
120MG
@
120MG
180MG
@
180MG
240MG
@
240MG
300MG
@
300MG
DILTIAZEM HYDROCHLORIDE
+
MYLAN
240MG
TIAZAC
VALEANT PHARMS NORTH 120MG
180MG
240MG
300MG
360MG
+
420MG
INJECTABLE;INJECTION
DILTIAZEM HYDROCHLORIDE
EUROHLTH INTL SARL
5MG/ML
AP
DIPHENHYDRAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
+
EUROHLTH INTL SARL
50MG/ML
A 080817
002
Jun CAHN
AP
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
EUROHLTH INTL SARL
A 074521
Jun CAHN
AB3
AB3
AB3
AB3
AB2
AB4
AB4
AB4
AB4
AB4
AB4
5MG/ML
Sep
Sep
Sep
Sep
Sep
Oct
11,
11,
11,
11,
11,
16,
1995
1995
1995
1995
1995
1998
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
AB
AP
AP
AB
AB
>A> AB
>A> AB
AB
AB
AB
AP
AB
2015
A 203916
A 203916
Feb NEWA
Feb NEWA
DIVALPROEX SODIUM
TABLET, EXTENDED RELEASE;ORAL
DIVALPROEX SODIUM
AMNEAL PHARMS
EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
@ G AND W LABS INC
EQ 500MG VALPROIC ACID
A 203730
A 203730
A 078700
May NEWA
May NEWA
Jul CAHN
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
@ IGI LABS INC
EQ 12.5MG BASE/ML
A 074098
Mar CAHN
A 203877
A 203877
Aug NEWA
Aug NEWA
DONEPEZIL HYDROCHLORIDE
TABLET;ORAL
DONEPEZIL HYDROCHLORIDE
HETERO LABS LTD V
5MG
10MG
LUPIN LTD
23MG
MYLAN PHARMS INC
23MG
SUN PHARM INDS LTD
5MG
10MG
23MG
A 203034
A 203034
A 202782
A 202656
A 076786
A 076786
A 204293
001
002
001
001
001
002
001
Jan
Jan
Oct
Oct
Apr
Apr
May
N 206439
N 206439
Mar CAHN
Mar CAHN
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@
@
@
40MG/ML
40MG/ML
80MG/ML
80MG/ML
80MG/ML
160MG/ML
160MG/ML
160MG/ML
A 070087
N 018656
A 070089
A 070090
A 070091
A 070092
A 070093
A 070094
001
001
001
001
001
001
001
001
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
DOXAPRAM HYDROCHLORIDE
INJECTABLE;INJECTION
DOPRAM
+
EUROHLTH INTL SARL
20MG/ML
N 014879
001
Jun CAHN
EQ 100MG BASE
EQ 150MG BASE
A 070791
A 071669
Jan CRLD
Jan CRLD
5%
N 020126
Mar CAHN
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
TEVA PHARMS USA
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
+
MYLAN PHARMS INC
+
PAR PHARM
CREAM;TOPICAL
ZONALON
+
DELCOR ASSET CORP
250MG
500MG
20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
1 -32
October
DISULFIRAM
TABLET;ORAL
DISULFIRAM
MYLAN PHARMS INC
10
Jan
Jan
Oct
Oct
Nov
Nov
Jun
Oct
Jun
Oct
Oct
Oct
Oct
Oct
Oct
30,
30,
30,
22,
26,
26,
05,
23,
28,
23,
23,
23,
23,
23,
23,
2015
2015
2015
2015
2010
2010
2015
1985
1983
1985
1985
1985
1985
1985
1985
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AP
>D>
>D>
>D>
>D>
>D>
>D>
>D>
>A> AP
>A>
>A>
>A>
>A>
>A>
>A>
>A> AP
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A>
>A>
>A>
>A>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
2015
A 203929
Apr NEWA
N 050629
N 050629
Oct CTNA
Oct CTNA
N 050467
N 050467
N 050467
N 050467
001
003 May 20, 1985
002
004 Jul 22, 1987
Oct
Oct
Oct
Oct
CTNA
CTNA
CTNA
CTNA
N 050629
N 050629
N 050467
N 050467
N 050467
N 050467
N 050629
N 050629
N 050629
001
001
001
003
002
004
003
002
002
Jul
Mar
May
May
22,
28,
03,
03,
1987
2011
1988
1988
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
CMFD
CTNA
CTNA
CTNA
CTNA
CTNA
NEWA
CMFD
CTNA
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
A 204446
A 204446
A 204446
A 065053
A 065053
A 065053
001
002
003
001
003
002
May
May
May
Nov
Sep
Nov
28,
28,
28,
22,
10,
22,
2015
2015
2015
2000
2003
2000
May
May
May
Apr
Apr
Apr
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
A 065356
A 065356
A 065356
Apr CAHN
Apr CAHN
Apr CAHN
DOXYCYCLINE HYCLATE
INJECTABLE;INJECTION
DOXYCYCLINE
@ EUROHLTH INTL SARL
@
EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
A 062450
A 062450
Jun CAHN
Jun CAHN
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
@ IGI LABS INC
@
@
2.5MG/ML
2.5MG/ML
2.5MG/ML
A 072019
A 072020
A 072021
Mar CAHN
Mar CAHN
Mar CAHN
A 204296
A 202594
Aug NEWA
Oct NEWA
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
DULOXETINE HYDROCHLORIDE
ALKEM LABS LTD
EQ 20MG
EQ 30MG
EQ 60MG
ANCHEN PHARMS
EQ 20MG
EQ 30MG
EQ 60MG
INVENTIA HLTHCARE
EQ 20MG
EQ 30MG
A 203197
A 203197
A 203197
A 090780
A 090780
A 090780
A 202336
A 202336
001
002
003
001
002
003
001
002
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
4MCG/2ML (2MCG/ML)
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ADRIAMYCIN PFS
@ PHARMACIA AND UPJOHN 2MG/ML
@
200MG/100ML
ADRIAMYCIN RDF
@ PHARMACIA AND UPJOHN
10MG/VIAL
@
20MG/VIAL
@
50MG/VIAL
@
150MG/VIAL
DOXORUBICIN HYDROCHLORIDE
+
PHARMACIA AND UPJOHN 2MG/ML
@
2MG/ML
@
10MG/VIAL
@
20MG/VIAL
@
50MG/VIAL
@
150MG/VIAL
150MG/75ML
+
200MG/100ML
@
200MG/100ML
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
NOVEL LABS INC
TABLET;ORAL
DOXYCYCLINE
SUN PHARM INDS LTD
EQ
EQ
EQ
EQ
EQ
EQ
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
1 -33
October
DOXERCALCIFEROL
INJECTABLE;INJECTION
DOXERCALCIFEROL
AKORN INC
10
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
26,
26,
26,
28,
28,
28,
28,
28,
2015
2015
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
>A> AB
AB
AB
ECONAZOLE NITRATE
CREAM;TOPICAL
ECONAZOLE NITRATE
FOUGERA PHARMS
+
PERRIGO NEW YORK
EDOXABAN TOSYLATE
TABLET;ORAL
SAVAYSA
DAIICHI SANKYO
+
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON
+
MYLAN INSTITUTIONAL
ELTROMBOPAG OLAMINE
FOR SUSPENSION;ORAL
PROMACTA
+
NOVARTIS PHARMS CORP
TABLET;ORAL
PROMACTA
NOVARTIS PHARMS CORP
2015
A 202336
Oct NEWA
1%
1%
A 076075
A 076479
Mar CRLD
Mar CRLD
EQ 15MG BASE
EQ 30MG BASE
EQ 60MG BASE
N 206316
N 206316
N 206316
Jan NEWA
Jan NEWA
Jan NEWA
10MG/ML
A 088873
Mar CRLD
EQ 25MG ACID/PACKET
N 207027
Aug NEWA
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
N 022291
N 022291
N 022291
N 022291
N 022291
N 022291
N 022291
N 022291
004
001
002
002
003
003
005
005
Oct
Nov
Nov
Nov
Sep
Sep
Nov
Nov
20,
20,
20,
20,
08,
08,
16,
16,
2011
2008
2008
2008
2009
2009
2012
2012
Mar
Mar
May
Mar
May
Mar
May
Mar
CAHN
CAHN
CRLD
CAHN
CRLD
CAHN
CRLD
CAHN
+
+
+
May
May
May
May
27,
27,
27,
27,
2015
2015
2015
2015
Jul
Jul
May
May
CAHN
CAHN
NEWA
NEWA
12.5MG ACID
25MG ACID
50MG ACID
50MG ACID
75MG ACID
75MG ACID
100MG ACID
100MG ACID
ELUXADOLINE
TABLET;ORAL
VIBERZI
FOREST TOSARA LTD
+
FURIEX PHARMS
+
75MG
100MG
75MG
100MG
N 206940
N 206940
N 206940
N 206940
001
002
001
002
EMPAGLIFLOZIN; LINAGLIPTIN
TABLET;ORAL
GLYXAMBI
BOEHRINGER INGELHEIM
+
10MG;5MG
25MG;5MG
N 206073
N 206073
Jan NEWA
Jan NEWA
N 206111
N 206111
N 206111
N 206111
001
002
003
004
Aug
Aug
Aug
Aug
26,
26,
26,
26,
2015
2015
2015
2015
Aug
Aug
Aug
Aug
NEWA
NEWA
NEWA
NEWA
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
A 075496
A 075496
A 075459
A 075459
A 075556
A 075556
A 075556
A 075556
001
002
001
002
001
002
003
004
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
22,
22,
22,
22,
22,
22,
22,
22,
2000
2000
2000
2000
2000
2000
2000
2000
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
CMFD
CMFD
CMFD
CMFD
CAHN
CAHN
CAHN
CAHN
2.5MG
N 018998
AB
AB
AB
AB
AB
1 -34
October
10
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
SANDOZ INC
Apr CAHN
10
1 -35
October
2015
N 018998
N 018998
N 018998
Apr CAHN
Apr CAHN
Apr CAHN
AB
AB
A 075727
A 075727
Apr CAHN
Apr CAHN
AB
ENTACAPONE
TABLET;ORAL
ENTACAPONE
AUROBINDO PHARMA LTD
200MG
A 203437
Jun NEWA
0.5MG
1MG
0.5MG
1MG
0.5MG
1MG
A 206652
A 206652
A 206217
A 206217
A 205740
A 205740
001
002
001
002
001
002
Oct
Oct
Aug
Aug
Aug
Aug
TABLET;ORAL
VASOTEC
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
>D>
>D>
>D>
>A>
>A>
>A>
AP
AP
AP
AP
AA
5MG
10MG
20MG
ENTECAVIR
TABLET;ORAL
ENTECAVIR
AMNEAL PHARMS
AUROBINDO PHARMA LTD
HETERO LABS LTD V
Nov
Nov
Aug
Aug
Aug
Aug
12,
12,
26,
26,
21,
21,
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
EPINEPHRINE
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS
ADRENALIN
+
PAR STERILE PRODUCTS
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
N 204200
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
ADRENALIN
+
PAR STERILE PRODUCTS
EQ 30MG BASE/30ML (EQ 1MG BASE/ML) N 204640
Jul CAIN
Jul CAIN
EPINEPHRINE HYDROCHLORIDE
SOLUTION;IV (INFUSION)
EPINEPHRINE
BELCHER PHARMS LLC
EQ 1MG BASE/ML
SOLUTION;IV (INFUSION), INTRAOCULAR
EPINEPHRINE
BELCHER PHARMS LLC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
N 205029
Oct CDFR
N 205029
Oct CDFR
A 080406
A 080406
001
002
Sep CAHN
Sep CAHN
N 021268
N 021268
Jun DISC
Jun DISC
2MG/ML
75MG/100ML
A 090854
A 091555
Jun NEWA
May NEWA
2MG/ML
75MG/100ML
N 020718
N 020718
Jun CTEC
May CFTG
50,000 IU
A 080704
001
Jan CAHN
EPTIFIBATIDE
INJECTABLE;INJECTION
EPTIFIBATIDE
TEVA PHARMS USA
+
+
INTEGRILIN
SCHERING
ERGOCALCIFEROL
CAPSULE;ORAL
VITAMIN D
BANNER LIFE SCIENCES
2015
2MG
A 088337
Aug CAHN
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
25MG BASE
100MG BASE
150MG BASE
100MG BASE
100MG BASE
100MG BASE
150MG BASE
150MG BASE
150MG BASE
A 091002
A 091002
A 091002
A 091059
A 091059
A 091059
A 091059
A 091059
A 091059
001
002
003
002
002
002
003
003
003
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Aug
11,
11,
11,
28,
28,
28,
28,
28,
28,
2014
2014
2014
2015
2015
2015
2015
2015
2015
Sep
Sep
Sep
Oct
Oct
Aug
Oct
Oct
Aug
DISC
DISC
DISC
DISC
DISC
NEWA
DISC
DISC
NEWA
>D> AB
>A>
AB
>D> AB
>A>
AB
EQ
EQ
EQ
EQ
EQ
25MG BASE
100MG BASE
100MG BASE
150MG BASE
150MG BASE
N 021743
N 021743
N 021743
N 021743
N 021743
001
002
002
003
003
Nov
Nov
Nov
Nov
Nov
18,
18,
18,
18,
18,
2004
2004
2004
2004
2004
Sep
Oct
Oct
Oct
Oct
CTEC
CTEC
CTEC
CTEC
CTEC
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
A 062169
A 062169
Apr CAHN
Apr CAHN
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE
@ ANI PHARMS INC
EQ 200MG BASE/5ML
A 062055
001
Jul CAHN
EQ 5MG BASE/5ML
A 203967
May NEWA
EQ
EQ
EQ
EQ
EQ
EQ
A 077550
A 077550
A 077550
A 078032
A 078032
A 078032
001
002
003
001
002
003
Apr
Apr
Apr
Aug
Aug
Aug
A 205520
A 201126
Jul NEWA
Feb NEWA
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
A 078279
A 078279
A 202784
A 202784
A 078003
A 078003
A 078936
A 078936
A 078936
A 078936
A 203636
A 203636
001
002
001
002
001
002
001
002
001
002
001
002
Sep
Sep
Sep
Sep
Jan
Jan
Jul
Jul
Sep
Sep
Oct
Oct
BASE
N 021153
ERLOTINIB HYDROCHLORIDE
TABLET;ORAL
ERLOTINIB HYDROCHLORIDE
@ MYLAN PHARMS INC
@
@
TEVA PHARMS USA
@
@
TARCEVA
OSI PHARMS
>D> AB
>A>
>D> AB
>A>
+
+
ERYTHROMYCIN ESTOLATE
SUSPENSION;ORAL
ERYTHROMYCIN ESTOLATE
@ G AND W LABS INC
@
AA
AB
AB
AB
AB
AB
AB
AP
AP
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
ESCITALOPRAM OXALATE
SOLUTION;ORAL
ESCITALOPRAM OXALATE
ANTRIM PHARMS LLC
TABLET;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC
PRINSTON INC
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
ESMOLOL HYDROCHLORIDE
AUROBINDO PHARMA LTD
LUITPOLD
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
10MG/ML
10MG/ML
ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS;ORAL
ESOMEPRAZOLE MAGNESIUM
DR REDDYS LABS LTD
EQ 20MG
EQ 40MG
HETERO LABS LTD III
EQ 20MG
EQ 40MG
IVAX SUB TEVA PHARMS EQ 20MG
EQ 40MG
MYLAN LABS LTD
EQ 20MG
EQ 40MG
MYLAN PHARMS INC
EQ 20MG
EQ 40MG
TORRENT PHARMS LTD
EQ 20MG
EQ 40MG
NEXIUM
ASTRAZENECA PHARMS
EQ 20MG
1 -36
October
ERGOTAMINE TARTRATE
TABLET;SUBLINGUAL
ERGOSTAT
@ WATSON LABS INC
10
May
May
May
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Jan
Jan
Aug
Aug
Aug
Aug
Oct
Oct
14,
14,
14,
28,
28,
28,
25,
25,
21,
21,
26,
26,
02,
03,
02,
03,
19,
19,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
Jan CFTG
AB
AP
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS
ESOMEPRAZOLE SODIUM
ACCORD HLTHCARE
2015
N 021153
Jan CFTG
A 205379
Sep NEWA
N 202342
N 202342
Aug CPOT
Aug CPOT
N 020655
N 020655
N 020655
N 020655
004
001
002
003
Mar
Mar
Mar
Mar
N 203752
Jan NEWA
A 040275
A 040275
A 040275
A 040275
A 040275
A 040275
001
002
003
001
002
003
Oct
Oct
Oct
Oct
Oct
Oct
A 205256
May DISC
1MG
2MG
3MG
A 202929
A 202929
A 202929
Jan NEWA
Jan NEWA
Jan NEWA
EQ 50MG BASE/VIAL
N 016093
001
Jul CFTG
EQ 50MG BASE/VIAL
A 205473
Jul NEWA
A 075095
A 075095
Jan CMFD
Jan CMFD
A 203163
Feb NEWA
A 202791
A 203164
A 079218
Mar NEWA
Jun NEWA
Mar CTEC
A 073594
Aug CRLD
N 018782
Aug DISC
A 201088
May NEWA
EQ 40MG BASE/VIAL
ESOMEPRAZOLE STRONTIUM
CAPSULE, DELAYED RELEASE;ORAL
ESOMEPRAZOLE STRONTIUM
HANMI PHARM CO LTD
24.65MG
+
49.3MG
BX
BX
BX
BX
>A>
>A>
>A>
>D>
>D>
>D>
AB
AB
AB
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
ALORA
ACTAVIS LABS UT INC
0.025MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
MINIVELLE
NOVEN
0.025MG/24HR
TABLET;ORAL
ESTRADIOL
@ EPIC PHARMA INC
0.5MG
@
1MG
@
2MG
@ HERITAGE PHARMS INC
0.5MG
@
1MG
@
2MG
TABLET;VAGINAL
ESTRADIOL
@ AMNEAL PHARMS
10MCG
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
MACLEODS PHARMS LTD
AP
ETHACRYNATE SODIUM
INJECTABLE;INJECTION
EDECRIN
+
ATON
ETHACRYNATE SODIUM
PAR STERILE PRODUCTS
AB
AB
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
ETHAMBUTOL HYDROCHLORIDE
VERSAPHARM INC
100MG
400MG
AP
1 -37
October
10
Apr
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
05,
20,
20,
20,
29,
29,
29,
29,
29,
29,
2002
1996
1996
1996
1998
1998
1998
1998
1998
1998
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AB
10
>A>
>A> AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
A 200910
001 Apr 16, 2014
Feb CRLD
N 017566
001
Mar CAHN
N 017565
001
Feb CAHN
N 018977
001 Apr 13, 1984
Feb CAHN
N 017743
001
Mar CAHN
A 200897
A 200897
A 200488
A 200489
A 203006
001
001
001
001
001
May
May
Oct
Oct
Aug
11,
11,
21,
21,
05,
2015
2015
2015
2015
2013
Apr
Jul
Oct
Oct
Jul
NEWA
CRLD
NEWA
NEWA
CTEC
N 017565
002
Feb CAHN
N 017716
001
Jul DISC
N 018977
002 Apr 13, 1984
Feb CAHN
0.035MG;0.25MG
JAI PHARMA LTD
0.025MG,0.025MG,0.025MG;0.18MG,0.2
15MG,0.25MG
OC PHARMA
0.035MG;0.035MG;0.035MG;0.18MG;0.2
15MG;0.25MG
0.035MG;0.25MG
TRI-LO-ESTARYLLA
SANDOZ INC
0.025MG,0.025MG,0.025MG;0.18MG,0.2
15MG,0.25MG
1 -38
October
2015
Oct NEWA
Mar CTEC
Feb NEWA
Mar CTEC
Mar NEWA
Mar NEWA
Jan CRLD
A 203870
001 Nov 12, 2015
Oct NEWA
A 203865
001 Oct 27, 2015
A 202132
001 Sep 09, 2015
Oct NEWA
Aug NEWA
A 200383
001 Apr 07, 2015
Mar NEWA
A 200384
001 Apr 07, 2015
Mar NEWA
A 091232
001 Jun 29, 2015
Jun NEWA
A 075288
002 Jul 28, 1999
Feb CMFD
AB
AB
AP
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
October
2015
1 -39
250MG
250MG
A 040430
A 200892
Jan CAHN
Sep CAHN
ETODOLAC
TABLET;ORAL
ETODOLAC
@ LEHIGH VALLEY
400MG
A 074927
Sep CAHN
ETONOGESTREL
IMPLANT;IMPLANTATION
IMPLANON
@ ORGANON USA INC
68MG/IMPLANT
N 021529
Jun DISC
10MG
10MG
A 078560
A 078560
Jun DISC
Jun NEWA
10MG
10MG
N 021445
N 021445
Jun CTEC
Jun CFTG
A 075488
A 075799
Jun CAHN
Sep CAHN
A 075486
Jun CAHN
20MG
40MG
N 019462
N 019462
Feb CAHN
Feb CAHN
400MG
600MG
A 202284
A 202284
Oct NEWA
Oct NEWA
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
FELODIPINE
ORCHID HLTHCARE
2.5MG
5MG
10MG
SUN PHARM INDS LTD
2.5MG
5MG
10MG
A 203032
A 203032
A 203032
A 091200
A 091200
A 091200
001
002
003
001
002
003
May
May
May
Apr
Apr
Apr
43MG
130MG
A 201748
A 201748
Apr CAHN
Apr CAHN
54MG
160MG
54MG
107MG
160MG
48MG
145MG
A 204019
A 204019
A 076635
A 076635
A 076635
A 090715
A 090715
001
002
001
002
003
001
002
Aug
Aug
Apr
Apr
Apr
Aug
Aug
AB
AP
ETHOSUXIMIDE
CAPSULE;ORAL
ETHOSUXIMIDE
BANNER LIFE SCIENCES
HERITAGE PHARMS INC
EZETIMIBE
TABLET;ORAL
EZETIMIBE
@ GLENMARK PHARMS LTD
AB
10
+
+
ZETIA
MSD INTL GMBH
FAMOTIDINE
INJECTABLE;INJECTION
FAMOTIDINE
+
EUROHLTH INTL SARL
@
FAMOTIDINE PRESERVATIVE
+
EUROHLTH INTL SARL
TABLET;ORAL
PEPCID
VALEANT PHARMS NORTH
+
FELBAMATE
TABLET;ORAL
FELBAMATE
COREPHARMA
FENOFIBRATE
CAPSULE;ORAL
FENOFIBRATE
SUN PHARM INDS LTD
TABLET;ORAL
FENOFIBRATE
LUPIN LTD
SUN PHARM INDS LTD
10MG/ML
10MG/ML
FREE
10MG/ML
May
May
May
Dec
Dec
Dec
Aug
Aug
Oct
Oct
Oct
Apr
Apr
21,
21,
21,
13,
13,
13,
17,
17,
31,
31,
31,
05,
05,
2015
2015
2015
2013
2013
2013
2015
2015
2005
2005
2005
2012
2012
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN
2015
N 022418
N 022418
Jun CAHN
Jun CAHN
A 076709
Mar CAHN
A 077154
Jun NEWA
A 076709
Mar CAHN
A 076709
Mar CAHN
A 076709
Mar CAHN
N 022266
N 022266
N 022266
N 022266
N 022266
001
002
003
004
005
Mar
Mar
Mar
Mar
Mar
N 019101
Feb CAHN
FENTANYL HYDROCHLORIDE
SYSTEM;IONTOPHORESIS, TRANSDERMAL
IONSYS
@ THE MEDICINES CO
10.8MCG
+
EQ 40MCG BASE/ACTIVATION
N 021338
N 021338
Apr CAHN
Jun CMFD
FERRIC CITRATE
TABLET;ORAL
AURYXIA
+
KERYX BIOPHARMS
N 205874
Jan CTNA
N 206317
N 206317
Jan NEWA
Oct NEWA
FIDAXOMICIN
TABLET;ORAL
DIFICID
+
CUBIST PHARMS LLC
200MG
N 201699
Aug CAHN
50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG
A 075882
A 075882
A 075882
A 202821
A 202821
A 202821
A 076421
A 076421
A 076421
001
002
003
001
002
003
001
002
003
Apr
Apr
Apr
Jun
Jun
Jun
Apr
Apr
Apr
35MG
105MG
AB
FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
FENTANYL-100
ACTAVIS LABS UT INC
100MCG/HR
FENTANYL-12
MALLINCKRODT INC
12.5MCG/HR
FENTANYL-25
ACTAVIS LABS UT INC
25MCG/HR
FENTANYL-50
ACTAVIS LABS UT INC
50MCG/HR
FENTANYL-75
ACTAVIS LABS UT INC
75MCG/HR
AP
FENTANYL CITRATE
FILM;BUCCAL
ONSOLIS
@ BIODELIVERY SCI INTL EQ 0.2MG BASE
@
EQ 0.4MG BASE
@
EQ 0.6MG BASE
@
EQ 0.8MG BASE
@
EQ 1.2MG BASE
INJECTABLE;INJECTION
FENTANYL CITRATE PRESERVATIVE FREE
+
EUROHLTH INTL SARL
EQ 0.05MG BASE/ML
AB
AB
AB
AB
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
ANI PHARMS INC
EQ 210MG IRON
1 -40
October
FENOFIBRIC ACID
TABLET;ORAL
FIBRICOR
TRIBUTE PHARMS INTL
+
10
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Jul
Jul
Jul
Mar
Mar
Mar
16,
16,
16,
16,
16,
28,
28,
28,
08,
08,
08,
28,
28,
28,
2009
2009
2009
2009
2009
2002
2002
2002
2015
2015
2015
2003
2003
2003
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
FLIBANSERIN
TABLET;ORAL
ADDYI
+
SPROUT PHARMS
AB
AB
AP
AP
AP
AP
AP
AP
AB
AB
AB
AB
>A> AP
AP
>A> AP
AP
AP
>D>
>A> AP
AP
AP
AP
FLUCONAZOLE
FOR SUSPENSION;ORAL
FLUCONAZOLE
SUN PHARM INDS LTD
10
100MG
N 022526
001 Aug 18, 2015
Aug NEWA
50MG/5ML
200MG/5ML
A 076332
001 Jul 29, 2004
A 076332
002 Jul 29, 2004
Apr CAHN
Apr CAHN
A 077988
001 May 26, 2010
A 077988
002 May 26, 2010
Apr CAHN
Apr CAHN
A 077947
001 May 26, 2010
A 077947
002 May 26, 2010
Apr CAHN
Apr CAHN
A 077909
A 077909
A 077909
A 077909
003
003
001
002
Apr
Apr
May
May
20,
20,
26,
26,
2015
2015
2010
2010
Apr
Apr
Apr
Apr
NEWA
CAHN
CAHN
CAHN
A 078423
A 078423
A 078423
A 078423
001
002
003
004
Mar
Mar
Mar
Mar
07,
07,
07,
07,
2011
2011
2011
2011
May
May
May
May
CMFD
CMFD
CMFD
CMFD
20-300mCi/ML
20-300mCi/ML
4-40mCi/ML
20-300mCi/ML
20-300mCi/ML
20-500mCi/ML
10-100mCi/ML
4-500mCi/ML
4-40mCi/ML
4-40mCi/ML
20-300mCi/ML
A 203778
A 203591
A 204759
A 203904
A 204472
A 204546
A 203771
A 203911
A 203811
A 203811
A 204531
001
001
001
001
001
001
001
001
001
001
001
Oct
Aug
Oct
Apr
Sep
Apr
Aug
Apr
Jun
Jun
Jul
30,
31,
27,
23,
11,
07,
31,
22,
27,
27,
17,
2015
2015
2015
2015
2015
2015
2015
2015
2013
2013
2015
Oct
Aug
Oct
Apr
Aug
Mar
Aug
Apr
Oct
Oct
Jul
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CTEC
CTEC
NEWA
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
A 076755
A 076755
A 076787
A 076787
002
001
002
001
Oct
Oct
Oct
Oct
12,
12,
12,
12,
2004
2004
2004
2004
Apr
Apr
Jun
Jun
CAHN
CAHN
CAHN
CAHN
0.01%
A 091514
001 Jun 25, 2015
Jun NEWA
0.01%
A 206422
001 Sep 02, 2015
Aug NEWA
INJECTABLE;INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
400MG/200ML (2MG/ML)
100MG/50ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
TABLET;ORAL
FLUCONAZOLE
HARRIS PHARM
50MG
100MG
150MG
200MG
FLUDEOXYGLUCOSE F-18
INJECTABLE;INTRAVENOUS
FLUDEOXYGLUCOSE F18
3D IMAGING DRUG
IBA MOLECULAR N AM
KETTERING MEDCTR
METHODIST HOSP RES
MIPS CRF
PRECISION NUCLEAR
QUEEN HAMAMATSU PET
SPECTRON MRC LLC
+
UCLA BIOMEDICAL
+
UNIV MICHIGAN
FLUMAZENIL
INJECTABLE;INJECTION
FLUMAZENIL
@ CLARIS PHARMASERVICE
@
EUROHLTH INTL SARL
1 -41
-
October
2015
AT
FLUOCINOLONE ACETONIDE
OIL;TOPICAL
FLUOCINOLONE ACETONIDE
VERSAPHARM INC
SOLUTION;TOPICAL
FLUOCINOLONE ACETONIDE
GAVIS PHARMS LLC
AB
FLUOCINONIDE
GEL;TOPICAL
FLUOCINONIDE
G AND W LABS INC
0.05%
A 072537
001 Feb 07, 1989
Apr CAHN
FLUOROURACIL
CREAM;TOPICAL
CARAC
+
VALEANT PHARMS NORTH
+
0.5%
0.5%
N 020985
001 Oct 27, 2000
N 020985
001 Oct 27, 2000
Apr CFTG
Feb CAHN
AT
AB
AB
2015
0.5%
A 203122
Apr NEWA
4%
N 022259
Sep NEWA
A 076287
A 076287
A 078045
A 078045
A 077469
A 077469
A 204597
A 204597
A 204597
A 076990
001
002
002
002
001
002
001
002
003
001
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Apr
0.05%
0.05%
N 012806
N 012806
001
001
Jun CRLD
May CMFD
0.004MG/SQ CM
N 016455
001
Mar CAHN
50MG
50MG
100MG
100MG
N 018766
N 018766
N 018766
N 018766
002
002
003
003
100MG
100MG
A 074358
A 074358
Oct CRLD
Oct CRLD
N 204275
Apr NEWA
FLUTICASONE PROPIONATE
CREAM;TOPICAL
FLUTICASONE PROPIONATE
PERRIGO NEW YORK
+
A 076793
A 076793
Oct CRLD
Oct CRLD
A 202458
Aug NEWA
N 021192
Aug CFTG
A 075897
A 075898
A 075897
A 075898
A 075897
A 075898
001
001
002
002
003
003
Jul
Jul
Jul
Jul
Jul
Jul
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE HYDROCHLORIDE
@ ANI PHARMS INC
EQ 10MG BASE
@
EQ 20MG BASE
+
MYLAN
EQ 20MG BASE
EQ 20MG BASE
@ SANDOZ
EQ 10MG BASE
@
EQ 20MG BASE
AB1
SCIEGEN PHARMS INC
EQ 10MG BASE
AB1
EQ 20MG BASE
AB
EQ 40MG BASE
AB
SUN PHARM INDS LTD
EQ 40MG BASE
FLURANDRENOLIDE
OINTMENT;TOPICAL
CORDRAN
+
AQUA PHARMS
TAPE;TOPICAL
CORDRAN
+
ACTAVIS LABS UT INC
>D>
>D> AB
>A>
>D> AB
>A>
>D> AB
>A> AB
>D> AB
>A> AB
AB
AB
AB
FLURBIPROFEN
TABLET;ORAL
ANSAID
PHARMACIA AND UPJOHN
@
+
@
FLURBIPROFEN
MYLAN
+
0.05%
0.05%
FLUVASTATIN SODIUM
TABLET, EXTENDED RELEASE;ORAL
FLUVASTATIN SODIUM
MYLAN PHARMS INC
80MG
LESCOL XL
+
NOVARTIS
80MG
FLUVOXAMINE MALEATE
TABLET;ORAL
FLUVOXAMINE MALEATE
ANI PHARMS INC
@
AB
@
AB
@
25MG
25MG
50MG
50MG
100MG
100MG
1 -42
October
CREAM;TOPICAL
FLUOROURACIL
SPEAR PHARMS INC
TOLAK
+
HILL DERMACEUTICALS
10
May
May
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Dec
Oct
Oct
Oct
Oct
Jan
Mar
Jan
Mar
Jan
Mar
20,
20,
17,
17,
17,
17,
16,
16,
16,
13,
31,
31,
31,
31,
25,
12,
25,
12,
25,
12,
2008
2008
2008
2008
2008
2008
2015
2015
2015
2004
1988
1988
1988
1988
2001
2001
2001
2001
2001
2001
Oct
Oct
Oct
Oct
DISC
DISC
CRLD
CTEC
DISC
DISC
NEWA
NEWA
NEWA
CAHN
DISC
DISC
DISC
DISC
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
10
1 -43
October
2015
A 091145
A 204418
Aug CAHN
Jul NEWA
AA
AA
FOLIC ACID
TABLET;ORAL
FOLIC ACID
AIPING PHARM INC
NUVO PHARM INC
AB
AB
A 076739
A 076739
Apr CAHN
Apr CAHN
FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
@ IGI LABS INC
@
10MG/ML
10MG/ML
A 070095
A 070096
Mar CAHN
Mar CAHN
100MG
300MG
400MG
A 076606
A 076606
A 076606
Apr CAHN
Apr CAHN
Apr CAHN
600MG
800MG
A 078782
A 078782
Jun DISC
Jun DISC
N 020937
N 020937
N 020937
N 020937
N 020975
001
002
003
004
001
Dec
Dec
Dec
Dec
Dec
08,
08,
08,
08,
08,
1999
1999
1999
1999
1999
Feb
Feb
Feb
Feb
Feb
CAHN
CAHN
CAHN
CAHN
CAHN
N 020976
N 020976
N 020976
N 020976
002
003
004
001
Dec
Dec
Dec
Dec
08,
08,
08,
08,
1999
1999
1999
1999
Feb
Feb
Feb
Feb
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
SUN PHARM INDS LTD
TABLET;ORAL
GABAPENTIN
@ HIKMA PHARMS
@
1MG
1MG
GADOVERSETAMIDE
INJECTABLE;INJECTION
OPTIMARK
+
LIEBEL-FLARSHEIM
1654.5MG/5ML (330.9MG/ML)
+
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
16.545GM/50ML (330.9MG/ML)
OPTIMARK IN PLASTIC CONTAINER
+
LIEBEL-FLARSHEIM
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
9927MG/30ML (330.9MG/ML)
AB
AB
AB
AP
AP
GEFITINIB
TABLET;ORAL
IRESSA
+
ASTRAZENECA PHARMS
250MG
N 206995
Jul NEWA
GEMFIBROZIL
TABLET;ORAL
GEMFIBROZIL
AUROBINDO PHARMA LTD
600MG
A 202726
Aug NEWA
EQ 320MG BASE
N 021158
Jun CFTG
EQ 320MG BASE
A 090466
Jun NEWA
20MG/ML
N 020622
Mar CFTG
20MG/ML
A 090218
Mar NEWA
GEMIFLOXACIN MESYLATE
TABLET;ORAL
FACTIVE
+
LG LIFE SCIENCES
GEMIFLOXACIN MESYLATE
ORCHID HLTHCARE
GLATIRAMER ACETATE
INJECTABLE;SUBCUTANEOUS
COPAXONE
+
TEVA PHARMS USA
GLATOPA
SANDOZ INC
2015
A 078952
A 078952
A 078952
Apr DISC
Apr DISC
Apr DISC
A 074387
A 074497
A 074387
A 074497
A 074497
A 074497
001
001
002
002
001
002
Aug
Oct
Aug
Oct
Oct
Oct
A 202298
A 202298
A 202298
May NEWA
May NEWA
May NEWA
N 201849
May NEWA
1.25MG
2.5MG
5MG
N 017532
N 017532
N 017532
Sep CFTG
Sep CFTG
Sep CFTG
1.25MG
2.5MG
5MG
1.25MG
1.25MG
2.5MG
2.5MG
5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG
A 077537
A 077537
A 077537
A 076257
A 206079
A 076257
A 206079
A 076257
A 206079
A 090937
A 090937
A 090937
A 074388
A 074388
A 074388
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
N 021178
N 021178
Oct DISC
Oct DISC
GLYCEROL PHENYLBUTYRATE
LIQUID;ORAL
RAVICTI
+
HORIZON THERAPS INC
1.1GM/ML
N 203284
May CAHN
0.2MG/ML
N 017558
001
Jun CAHN
15.6MCG/INH
N 207923
Oct NEWA
1MG
A 040844
Apr CAHN
1MG
2MG
4MG
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
@ ANI PHARMS INC
>A> AB
>A> AB
>D> AB
>D> AB
AB
AB
AB
5MG
5MG
@
10MG
10MG
IVAX SUB TEVA PHARMS
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL
GLIPIZIDE
MYLAN PHARMS INC
2.5MG
5MG
10MG
GLUCAGON HYDROCHLORIDE
POWDER;INTRAMUSCULAR, INTRAVENOUS
GLUCAGON
+
FRESENIUS KABI USA
EQ 1MG BASE/VIAL
GLYBURIDE
TABLET;ORAL
DIABETA
AB2
SANOFI AVENTIS US
AB2
AB2
+
GLYBURIDE
AB1
AUROBINDO PHARMA
AB1
AB1
AB1
COREPHARMA
AB2
AB1
AB2
AB1
AB2
AB1
HERITAGE PHARMS INC
AB1
AB1
AB1
TEVA
AB1
AB1
+
>D> AB
>A>
AP
>A>
>A>
>A>
AA
GLYCOPYRROLATE
INJECTABLE;INJECTION
ROBINUL
+
EUROHLTH INTL SARL
POWDER;INHALATION
SEEBRI
+
NOVARTIS PHARMS CORP
TABLET;ORAL
GLYCOPYRROLATE
SUN PHARM INDS LTD
1 -44
October
GLIMEPIRIDE
TABLET;ORAL
GLIMEPIRIDE
@ HIKMA PHARMS
@
@
10
Mar
Aug
Mar
Aug
Aug
Aug
Oct
Oct
Oct
Jun
Sep
Jun
Sep
Jun
Sep
Feb
Feb
Feb
Aug
Aug
Aug
04,
31,
04,
31,
31,
31,
18,
18,
18,
27,
30,
27,
30,
27,
30,
28,
28,
28,
29,
29,
29,
1996
1995
1996
1995
1995
1995
2007
2007
2007
2002
2015
2002
2015
2002
2015
2011
2011
2011
1995
1995
1995
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CTEC
CTEC
CTEC
CTEC
NEWA
CTEC
NEWA
CTEC
NEWA
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
10
1 -45
October
2015
TABLET;ORAL
GLYCOPYRROLATE
AA
>A>
>A>
>A>
>A>
2MG
GLYCOPYRROLATE ; INDACATEROL MALEATE
POWDER;INHALATION
UTIBRON
+
NOVARTIS PHARMS CORP
15.6MCG/INH;27.5MCG/INH
AP
AP
AP
AP
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
BANNER LIFE SCIENCES
EQ 0.1MG BASE/ML (EQ 0.1MG
BASE/ML)
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Apr CAHN
N 207930
001 Oct 29, 2015
Oct NEWA
A 078863
001 Jun 30, 2008
Jan CAHN
A 078880
A 078198
A 078198
A 077177
Jan
Apr
Apr
Jun
001
001
002
001
Jun
Jun
Jun
Dec
30,
30,
30,
31,
2008
2008
2008
2007
CAHN
CAHN
CAHN
CAHN
A 078863
002 Jun 30, 2008
Jan CAHN
N 022424
001 May 14, 2015
N 022424
001 May 14, 2015
May NEWA
Sep CAHN
May NEWA
GUANFACINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
GUANFACINE HYDROCHLORIDE
IMPAX LABS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
MYLAN PHARMS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
SANDOZ INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
TEVA PHARMS USA
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
TWI PHARMS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
>A>
>A>
>A>
>A>
A 040844
002 Aug 18, 2009
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
A 202238
A 202238
A 202238
A 202238
A 202578
A 202578
A 202578
A 202578
A 202568
A 202568
A 202568
A 202568
A 201382
A 201382
A 201382
A 201382
A 201408
A 201408
A 201408
A 201408
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
20,
20,
20,
20,
02,
02,
02,
02,
03,
03,
03,
03,
02,
02,
02,
02,
02,
02,
02,
02,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
Oct
Oct
Oct
Oct
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
001
001
001
001
001
001
Feb
Feb
Feb
May
May
Feb
17,
17,
17,
12,
12,
17,
1987
1987
1987
1987
1987
1987
May
Jun
Jun
Jun
May
Jun
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
HALOPERIDOL
TABLET;ORAL
HALOPERIDOL
@ CYCLE PHARMS LTD
@
@
@
@
@ ROXANE
0.5MG
1MG
5MG
10MG
20MG
2MG
A 071128
A 071129
A 071131
A 071132
A 071133
A 071130
HALOPERIDOL LACTATE
CONCENTRATE;ORAL
HALOPERIDOL INTENSOL
@ CYCLE PHARMS LTD
EQ 2MG BASE/ML
A 072045
001 Apr 12, 1988
May CAHN
INJECTABLE;INJECTION
HALOPERIDOL
@ CLARIS PHARMASERVICE
@
AP
AP
AP
AP
AP
AP
AB
AB
AB
AB
AB
AB
AB
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
@ EUROHLTH INTL SARL
+
@
@
@
+
@
@
@
+
@
@
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
@ SUN PHARM INDS INC
MICROZIDE
+
ACTAVIS LABS UT INC
2015
EQ 5MG BASE/ML
EQ 5MG BASE/ML
A 076791
A 076828
Apr CAHN
May CAHN
1,000 UNITS/ML
1,000 UNITS/ML
2,500 UNITS/ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
7,500 UNITS/ML
10,000 UNITS/ML
10,000 UNITS/ML
15,000 UNITS/ML
20,000 UNITS/ML
N 017007
N 017037
N 017007
N 017007
N 017007
N 017037
N 017037
N 017007
N 017007
N 017037
N 017007
N 017007
001
001
007
002
010
002
013 Apr 07, 1986
003
004
003
005
006
Aug
Jun
Aug
Aug
Aug
Jun
Jun
Aug
Aug
Jun
Aug
Aug
A 040730
A 040136
A 203110
Feb CRLD
Feb CRLD
Jun NEWA
A 040858
A 040858
A 040858
A 040858
001
002
003
004
Sep
Sep
Sep
Sep
12.5MG
A 090651
Aug DISC
12.5MG
N 020504
Feb CAHN
A 076007
A 076007
A 076007
Apr CAHN
Apr CAHN
Apr CAHN
N 019888
N 019888
N 019888
Feb CAHN
Feb CAHN
Feb CAHN
N 021956
N 021956
N 021956
Jun CAHN
Jun CAHN
Jun CAHN
N 018031
N 018031
001
001
Oct DISC
Oct DISC
A 070704
A 072042
A 070705
A 072043
A 070947
A 070947
001
001
001
001
002
002
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SUN PHARM INDS LTD
12.5MG;10MG
12.5MG;20MG
25MG;20MG
ZESTORETIC
ALVOGEN IPCO SARL
12.5MG;10MG
+
12.5MG;20MG
+
25MG;20MG
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DUTOPROL
CONCORDIA PHARMS INC 12.5MG;EQ 25MG TARTRATE
12.5MG;EQ 50MG TARTRATE
+
12.5MG;EQ 100MG TARTRATE
>D>
>D> AB
>A>
AB
AB
>D> AB
>A> AB
1 -46
October
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDRALAZINE HYDROCHLORIDE
+
AKORN
20MG/ML
LUITPOLD
20MG/ML
X-GEN PHARMS INC
20MG/ML
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
@ HERITAGE PHARMS INC
10MG
@
25MG
@
50MG
@
100MG
10
Feb
Feb
Feb
Feb
Oct
Mar
Oct
Mar
Mar
Mar
26,
26,
26,
26,
01,
14,
01,
14,
04,
04,
2010
2010
2010
2010
1986
1988
1986
1988
1987
1987
Jul
Aug
Jul
Aug
Oct
Oct
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CRLD
CRLD
2015
A 078211
A 078211
A 078211
Apr CAHN
Apr CAHN
Apr CAHN
>A> AB
>A> AB
>A> AB
HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET;ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDE
MACLEODS PHARMS LTD
12.5MG;40MG
12.5MG;80MG
25MG;80MG
A 204169
A 204169
A 204169
Oct NEWA
Oct NEWA
Oct NEWA
A 074970
Aug CAHN
AB
HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
@ ANI PHARMS INC
25MG;37.5MG
TABLET;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANI PHARMS INC
50MG;75MG
A 073467
Aug CAHN
HYDROCODONE BITARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
ZOHYDRO ER
+
FERRIMILL LTD
10MG
15MG
20MG
30MG
40MG
50MG
+
PERNIX IRELAND PAIN
10MG
15MG
20MG
30MG
40MG
50MG
TABLET, EXTENDED RELEASE;ORAL
HYSINGLA
+
PURDUE PHARMA LP
20MG
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
001
002
003
004
005
006
001
002
003
004
005
006
Apr
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
N 206627
Mar CRLD
A 040879
Mar CAHN
A 085982
001
Apr DISC
A 083365
A 083365
A 083365
Feb NEWA
Feb NEWA
Feb CMFD
HYDROCORTISONE ACETATE
POWDER;FOR RX COMPOUNDING
HYDROCORTISONE ACETATE
@ X GEN PHARMS
100%
A 085981
001
Apr DISC
HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
@ G AND W LABS INC
0.2%
A 074489
Apr CAHN
N 060613
001
Jun CMS2
AT
AB
AB
AB
AT
HYDROCORTISONE
CREAM;TOPICAL
HYDROCORTISONE
RISING PHARMS INC
2.5%
POWDER;FOR RX COMPOUNDING
HYDRO-RX
@ X GEN PHARMS
100%
TABLET;ORAL
HYDROCORTISONE
HIKMA INTL PHARMS
5MG
10MG
20MG
CORTISPORIN
+
CITRON PHARMA LLC
1%;EQ 3.5MG BASE/ML;10,000
UNITS/ML
1 -47
October
AB
AB
AB
10
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
>D>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AP
AP
AB
AB
AB
HYDROMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
DILAUDID-HP
+
PURDUE PHARM PRODS
250MG/VIAL
@
250MG/VIAL
TABLET, EXTENDED RELEASE;ORAL
HYDROMORPHONE HYDROCHLORIDE
PADDOCK LLC
8MG
12MG
16MG
10
1 -48
October
2015
N 019034
N 019034
Oct DISC
Oct DISC
A 204278
A 204278
A 204278
Mar NEWA
Mar NEWA
Mar NEWA
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
CYANOKIT
@ SERB SAS
+
2.5GM/VIAL (5GM/KIT)
5GM/VIAL (5GM/KIT)
N 022041
N 022041
Apr CAHN
Apr CAHN
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
PLAQUENIL
+
CONCORDIA PHARMS INC
200MG
N 009768
001
Jun CAHN
HYDROXYPROGESTERONE CAPROATE
INJECTABLE;INJECTION
HYDROXYPROGESTERONE CAPROATE
@ ACTAVIS LABS UT INC
125MG/ML
@
250MG/ML
+
MCGUFF
250MG/ML
N 017439
N 017439
A 200271
001
002
001 Aug 24, 2015
Mar CAHN
Mar CAHN
Aug NEWA
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
ELITE LABS INC
10MG
25MG
50MG
HERITAGE PHARMA
10MG
25MG
50MG
MIKAH PHARMA
10MG
25MG
50MG
@ MUTUAL PHARM
10MG
@
25MG
@
50MG
@ WATSON LABS
10MG
@
25MG
@
50MG
A 040600
A 040602
A 040604
A 204279
A 204279
A 204279
A 040600
A 040602
A 040604
A 089381
A 089382
A 089383
A 088348
A 088349
A 088350
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Jul
Jul
EQ 25MG HYDROCHLORIDE
EQ 50MG HYDROCHLORIDE
A 201507
A 201507
Mar CAHN
Mar CAHN
EQ 3MG BASE/3ML
EQ 3MG BASE/3ML
A 204222
A 205332
Oct NEWA
Aug NEWA
400MG
600MG
800MG
300MG
400MG
600MG
800MG
A 091625
A 091625
A 091625
A 071230
A 071231
A 071232
A 072004
001
002
003
001
001
001
001
Aug
Aug
Aug
Jul
Jul
Jul
Jul
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HYDROXYZINE PAMOATE
HERITAGE PHARMA
IBANDRONATE SODIUM
INJECTABLE;INTRAVENOUS
IBANDRONATE SODIUM
APOTEX INC
AUROBINDO PHARMA LTD
IBUPROFEN
TABLET;ORAL
IBUPROFEN
GRANULES INDIA LTD
@ VINTAGE PHARMS
@
@
@
Dec
Dec
Dec
Aug
Aug
Aug
Dec
Dec
Dec
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Nov
28,
28,
28,
20,
20,
20,
28,
28,
28,
19,
19,
19,
15,
15,
15,
15,
15,
15,
22,
22,
22,
18,
2004
2004
2004
2014
2014
2014
2004
2004
2004
1986
1986
1986
1983
1983
1983
2015
2015
2015
1986
1986
1986
1987
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CMFD
CMFD
CMFD
DISC
DISC
DISC
DISC
DISC
DISC
NEWA
NEWA
NEWA
DISC
DISC
DISC
DISC
2015
1MG
2MG
4MG
6MG
8MG
10MG
12MG
N 022192
N 022192
N 022192
N 022192
N 022192
N 022192
N 022192
001
002
003
004
005
006
007
AB
5%
A 200481
Apr CAHN
AB
1.25MG
1.25MG
2.5MG
2.5MG
A 074299
A 074498
A 074299
A 074498
002
002
001
001
Jul
Jul
Jul
Jul
INDOMETHACIN
CAPSULE, EXTENDED RELEASE;ORAL
INDOMETHACIN
JUBILANT GENERICS
75MG
A 202706
Sep NEWA
INGENOL MEBUTATE
GEL;TOPICAL
PICATO
+
LEO PHARMA AS
0.015%
N 202833
May CRLD
INSULIN DEGLUDEC
SOLUTION;SUBCUTANEOUS
TRESIBA
NOVO NORDISK INC
+
N 203314
N 203314
Sep NEWA
Sep NEWA
N 206538
Feb NEWA
200 UNITS/ML
N 205747
May NEWA
12 UNITS/INH
N 022472
Apr NEWA
IOHEXOL
FOR SOLUTION;ORAL
ORALTAG
INTERPHARMA PRAHA AS
9.7GM/BOT
N 205383
Mar NEWA
51%
A 074679
Jan DISC
61%
A 074679
Jan DISC
76%
A 074679
Jan DISC
41%
N 018735
Feb CTEC
IMIQUIMOD
CREAM;TOPICAL
IMIQUIMOD
G AND W LABS INC
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
ANI PHARMS INC
@
AB
@
AB
IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL-250
@ FRESENIUS KABI USA
IOPAMIDOL-300
@ FRESENIUS KABI USA
IOPAMIDOL-370
@ FRESENIUS KABI USA
ISOVUE-200
+
BRACCO
1 -49
October
ILOPERIDONE
TABLET;ORAL
FANAPT
+
VANDA PHARMS INC
10
May
May
May
May
May
May
May
Apr
Feb
Jul
Oct
06,
06,
06,
06,
06,
06,
06,
29,
12,
27,
31,
2009
2009
2009
2009
2009
2009
2009
1996
1998
1995
1996
Jan
Jan
Jan
Jan
Jan
Jan
Jan
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
AP
AP
INJECTABLE;INJECTION
ISOVUE-250
+
BRACCO
+
ISOVUE-300
+
BRACCO
ISOVUE-370
+
BRACCO
SCANLUX-300
MYLAN INSTITUTIONAL
SCANLUX-370
MYLAN INSTITUTIONAL
IOTHALAMATE MEGLUMINE
INJECTABLE;INJECTION
CONRAY
+
LIEBEL-FLARSHEIM
CONRAY 30
+
LIEBEL-FLARSHEIM
CONRAY 43
+
LIEBEL-FLARSHEIM
SOLUTION;INTRAVESICAL
CYSTO-CONRAY II
LIEBEL-FLARSHEIM
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 160
@ LIEBEL-FLARSHEIM
OPTIRAY 240
+
LIEBEL-FLARSHEIM
@
OPTIRAY 300
+
LIEBEL-FLARSHEIM
+
OPTIRAY 320
+
LIEBEL-FLARSHEIM
@
+
@
OPTIRAY 350
+
LIEBEL-FLARSHEIM
+
>D>
>A>
AB
AB
AB
IRBESARTAN
TABLET;ORAL
IRBESARTAN
JUBILANT GENERICS
2015
51%
51%
N 018735
N 020327
Feb CTEC
Feb CTEC
61%
N 020327
Feb CTEC
76%
N 020327
Feb CTEC
61%
A 090394
Aug CAHN
76%
A 090394
Aug CAHN
60%
N 013295
001
Feb CAHN
30%
N 016983
001
Feb CAHN
43%
N 013295
002
Feb CAHN
17.2%
N 017057
002
Feb CAHN
34%
N 019710
Feb CAHN
51%
51%
N 019710
N 020923
Feb CAHN
Feb CAHN
64%
64%
N 019710
N 020923
Feb CAHN
Feb CAHN
68%
68%
68%
68%
N 019710
N 020923
N 020923
N 020923
001
002
002
002
Feb
Oct
Oct
Feb
74%
74%
N 019710
N 020923
Feb CAHN
Feb CAHN
N 018905
May DISC
A 203534
A 203534
A 203534
Feb NEWA
Feb NEWA
Feb NEWA
N 207793
Oct NEWA
N 017441
001
Mar CAHN
75MG
150MG
300MG
IRINOTECAN HYDROCHLORIDE
INJECTABLE, LIPOSOMAL;IV (INFUSION)
ONIVYDE
+
MERRIMACK PHARMS
EQ 43MG BASE/10ML (EQ 4.3MG
BASE/ML)
>A>
>A>
BP
IRON DEXTRAN
INJECTABLE;INJECTION
INFED
+
ACTAVIS LABS UT INC
EQ 50MG IRON/ML
1 -50
October
10
Dec
May
May
May
30,
29,
29,
29,
1988
1998
1998
1998
CAHN
CMFD
CMFD
CAHN
2015
186MG
N 207500
Mar NEWA
372MG
N 207501
Mar NEWA
AB
5MG
40MG
N 012093
N 012093
Feb CAHN
Feb CAHN
25MG
35MG
N 021951
N 021951
Feb NEWA
Feb NEWA
30MG
A 076485
Aug NEWA
10MG
20MG
30MG
40MG
A 076041
A 076041
A 076503
A 076041
001
002
001
003
Apr
Apr
Apr
Apr
30MG
A 202099
Feb NEWA
2.5MG
5MG
A 077169
A 077169
Mar CAHN
Mar CAHN
10MG/ML
A 205573
Oct NEWA
10MG/ML
10MG/ML
N 020657
N 020657
Oct CFTG
Oct CFTG
IVABRADINE HYDROCHLORIDE
TABLET;ORAL
CORLANOR
AMGEN INC
+
EQ 5MG BASE
EQ 7.5MG BASE
N 206143
N 206143
Apr NEWA
Apr NEWA
IVACAFTOR
GRANULE;ORAL
KALYDECO
VERTEX PHARMS INC
+
50MG/PACKET
75MG/PACKET
N 207925
N 207925
Mar NEWA
Mar NEWA
IVACAFTOR; LUMACAFTOR
TABLET;ORAL
ORKAMBI
+
VERTEX PHARMS INC
125MG;200MG
N 206038
Jul NEWA
IXABEPILONE
INJECTABLE;IV (INFUSION)
IXEMPRA KIT
+
R-PHARM US LLC
+
15MG/VIAL
45MG/VIAL
N 022065
N 022065
Jun CAHN
Jun CAHN
ISOSORBIDE DINITRATE
TABLET;ORAL
ISORDIL
VALEANT PHARMS NORTH
+
ISOTRETINOIN
CAPSULE;ORAL
ABSORICA
RANBAXY
AB
AB
AB
AB
AB
AB
AB
AB
>A>
>A> AA
>D>
>A> AA
MYORISAN
DOUGLAS PHARMS
SOTRET
SUN PHARM INDS LTD
ZENATANE
DR REDDYS LABS LTD
ISRADIPINE
CAPSULE;ORAL
ISRADIPINE
ELITE LABS INC
ITRACONAZOLE
SOLUTION;ORAL
ITRACONAZOLE
AMNEAL PHARMS
SPORANOX
+
JANSSEN PHARMS
+
1 -51
October
ISAVUCONAZONIUM SULFATE
CAPSULE;ORAL
CRESEMBA
+
ASTELLAS
POWDER;IV (INFUSION)
CRESEMBA
+
ASTELLAS
10
Dec
Dec
Jun
Dec
24,
24,
20,
24,
2002
2002
2003
2002
CAHN
CAHN
CAHN
CAHN
October
2015
1 -52
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML
A 062324
A 062324
A 062324
001
002
003
Jun CAHN
Jun CAHN
Jun CAHN
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
A 203242
A 203242
A 075631
A 075631
A 075772
A 075772
001
002
002
001
001
002
15.75MG/SPRAY
N 022382
Jan CAHN
N 205388
Feb CPOT
A 076051
Apr CAHN
A 075215
A 075215
A 075215
Jan CMFD
Jan CMFD
Jan CMFD
A 203762
Mar NEWA
N 206510
N 206510
Aug DISC
Feb NEWA
AB
AB
AB
LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
LAMIVUDINE AND ZIDOVUDINE
HETERO LABS LTD III
150MG;300MG
STRIDES ARCOLAB LTD
150MG;300MG
STRIDES PHARMA
150MG;300MG
A 079124
A 079128
A 079128
Aug NEWA
Apr NEWA
Aug CAHN
A 078134
A 078134
A 078134
A 078134
001
002
003
004
Apr
Apr
Apr
Apr
19,
19,
19,
19,
2011
2011
2011
2011
May
May
May
May
DISC
DISC
DISC
DISC
AB
AB
AB
AB
LAMOTRIGINE
TABLET;ORAL
LAMOTRIGINE
@ HIKMA PHARMS
25MG
@
100MG
@
150MG
@
200MG
TABLET, ORALLY DISINTEGRATING;ORAL
LAMOTRIGINE
PAR PHARM
25MG
50MG
100MG
200MG
A 204158
A 204158
A 204158
A 204158
001
002
003
004
Oct
Oct
Oct
Oct
27,
27,
27,
27,
2015
2015
2015
2015
Oct
Oct
Oct
Oct
NEWA
NEWA
NEWA
NEWA
KANAMYCIN SULFATE
INJECTABLE;INJECTION
KANAMYCIN
@ EUROHLTH INTL SARL
@
@
AP
AP
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
BD RX
@ CLARIS PHARMASERVICE
@
@ EUROHLTH INTL SARL
@
SPRAY, METERED;NASAL
SPRIX
+
EGALET US INC
>A>
>A>
>A>
>A>
AB
AB
AB
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
@ CLARIS PHARMASERVICE 5MG/ML
TABLET;ORAL
LABETALOL HYDROCHLORIDE
MUTUAL PHARM
100MG
200MG
300MG
AA
LACTULOSE
SOLUTION;ORAL, RECTAL
LACTULOSE
BIO-PHARM INC
10GM/15ML
10
Oct
Oct
Jun
Jun
Jul
Jul
07,
07,
29,
29,
21,
21,
2015
2015
2001
2001
2004
2004
Sep
Sep
Apr
Apr
Jun
Jun
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
AP
AA
AB
AB
AB
AB
AB
AB
AP
AP
AP
AP
AP
AP
AP
AP
AP
AT
AB
AB
October
2015
1 -53
LAPATINIB DITOSYLATE
TABLET;ORAL
TYKERB
+
NOVARTIS PHARMS CORP
EQ 250MG BASE
N 022059
Mar CAHN
LENVATINIB MESYLATE
CAPSULE;ORAL
LENVIMA
EISAI INC
+
EQ 4MG BASE
EQ 10MG BASE
N 206947
N 206947
Feb NEWA
Feb NEWA
500MG/5ML (100MG/ML)
A 090876
Jul NEWA
100MG/ML
A 201157
May NEWA
N 207958
N 207958
N 207958
N 207958
001
002
003
004
Jul
Jul
Jul
Jul
31,
31,
31,
31,
2015
2015
2015
2015
Jul
Jul
Jul
Jul
NEWA
NEWA
NEWA
NEWA
A 202958
A 202167
A 202167
A 201464
A 201464
A 203468
A 203468
001
001
002
001
002
001
002
Feb
Sep
Sep
May
May
May
May
25,
04,
04,
25,
25,
21,
21,
2015
2015
2015
2012
2012
2015
2015
Feb
Aug
Aug
Aug
Aug
May
May
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
A 075881
Apr DISC
A 203027
A 201653
Feb NEWA
Jun NEWA
A 091436
A 078577
A 078577
Apr CAHN
Jul NEWA
Jul NEWA
A 091397
A 091397
A 091397
A 078579
A 078579
A 078579
001
002
003
001
002
003
Apr
Apr
Apr
Aug
Aug
Aug
A 077700
Jul CRLD
N 021199
Jul DISC
A 203613
A 203613
Jun NEWA
Jun NEWA
LEVETIRACETAM
INJECTABLE;IV (INFUSION)
LEVETIRACETAM
FRESENIUS KABI USA
SOLUTION;ORAL
LEVETIRACETAM
PHARM ASSOC
TABLET;ORAL
SPRITAM
APRECIA PHARMS CO
250MG
500MG
750MG
1GM
TABLET, EXTENDED RELEASE;ORAL
LEVETIRACETAM
APOTEX INC
1GM
DEXCEL PHARMA
500MG
750MG
PHARMADAX INC
500MG
750MG
PRINSTON INC
500MG
750MG
LEVOCARNITINE
INJECTABLE;INJECTION
LEVOCARNITINE
@ TEVA PHARMS USA
AB
AB
10
200MG/ML
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
APOTEX INC
5MG
SUN PHARM INDS LTD
5MG
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN
CLARIS PHARMASERVICE
HOSPIRA INC
Aug
Aug
Aug
Sep
Sep
Sep
08,
08,
08,
03,
03,
03,
2013
2013
2013
2015
2015
2015
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
>A> AP
2015
A 203576
Oct NEWA
A 203576
Oct NEWA
A 203563
Feb NEWA
A 203563
Oct CTEC
A 203563
Oct CTEC
A 203563
Feb NEWA
A 203563
Oct CTEC
A 203563
Oct CTEC
A 203563
Mar CRLD
LEVONORGESTREL
INTRAUTERINE DEVICE;INTRAUTERINE
LILETTA
MEDICINES360
52MG
N 206229
Feb NEWA
LEVORPHANOL TARTRATE
TABLET;ORAL
LEVORPHANOL TARTRATE
+
SENTYNL THERAPS INC
2MG
A 074278
Apr CAHN
5%
5%
A 206297
A 080210
Jul NEWA
Sep CAHN
5%
5%
A 200675
A 202346
Mar CAHN
Jul NEWA
A 080407
A 080407
A 091564
001
002
001 Aug 14, 2015
Mar CAHN
Mar CAHN
Aug NEWA
A 084625
A 084625
001
002
Feb CAHN
Feb CAHN
2%
A 080429
001
Jan CAHN
2%
A 081318
Apr CAHN
LIDOCAINE; PRILOCAINE
CREAM;TOPICAL
EMLA
+
ACTAVIS LABS UT INC
2.5%;2.5%
N 019941
Feb CAHN
LINACLOTIDE
CAPSULE;ORAL
LINZESS
FOREST LABS LLC
+
145MCG
290MCG
N 202811
N 202811
Mar CAHN
Mar CAHN
>A> AP
SANDOZ
>D>
SANDOZ INC
>A> AP
>D>
>A> AP
+
+
AT
AB
AB
AP
AB
LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
AMNEAL PHARMS
@ BELMORA LLC
PATCH;TOPICAL
LIDOCAINE
ACTAVIS LABS UT INC
MYLAN TECHNOLOGIES
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
@ EUROHLTH INTL SARL
@
LUITPOLD
LIDOCAINE HYDROCHLORIDE
@ EUROHLTH INTL SARL
@
JELLY;TOPICAL
ANESTACON
@ BANNER LIFE SCIENCES
LIDOCAINE HYDROCHLORIDE
@ G AND W LABS INC
EQ 175MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)
1%
2%
1%
PRESERVATIVE FREE
1%
2%
1 -54
October
LEVOLEUCOVORIN CALCIUM
SOLUTION;IV (INFUSION)
LEVOLEUCOVORIN CALCIUM
MYLAN TEORANTA
10
October
2015
1 -55
EQ 300MG BASE/ML
N 050317
001
May CFTG
EQ 300MG BASE/ML
A 201746
May NEWA
100MG/5ML
A 200068
May NEWA
100MG/5ML
N 021132
May CFTG
(2MG/ML)
(2MG/ML)
(2MG/ML)
(2MG/ML)
PLASTIC CONTAINER
(2MG/ML)
A 205442
A 200904
A 200904
A 200222
001
001
002
001
Jun
Jul
Jul
May
N 206473
Jun NEWA
(2MG/ML)
(2MG/ML)
(2MG/ML)
(2MG/ML)
N 021131
N 021131
N 021131
N 021131
001
001
002
003
Jul
May
May
May
A 078061
May NEWA
N 021130
May CFTG
2.5MG
5MG
10MG
20MG
30MG
40MG
A 075944
A 075944
A 075944
A 075944
A 075944
A 075944
001
002
003
004
006
005
Jul
Jul
Jul
Jul
Feb
Jul
01,
01,
01,
01,
11,
01,
2002
2002
2002
2002
2003
2002
Apr
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
2.5MG
5MG
10MG
20MG
30MG
40MG
N 019777
N 019777
N 019777
N 019777
N 019777
N 019777
005
001
002
003
006
004
Apr
May
May
May
Jan
May
29,
19,
19,
19,
20,
19,
1993
1988
1988
1988
1999
1988
Feb
Feb
Feb
Feb
Feb
Feb
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
LITHIUM CARBONATE
TABLET, EXTENDED RELEASE;ORAL
LITHIUM CARBONATE
ALEMBIC PHARMS LTD
300MG
@ HIKMA INTL PHARMS
450MG
UNIQUE PHARM LABS
300MG
A 204445
A 076490
A 204779
May NEWA
Feb DISC
Jul NEWA
EQ 30MG BASE
EQ 40MG BASE
EQ 60MG BASE
N 203858
N 203858
N 203858
Apr NEWA
Apr NEWA
Apr NEWA
5MG
N 017588
Jan NEWA
AP
AP
AB
AB
AP
AP
AP
AP
AP
AP
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
LINCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
LINCOCIN
+
PHARMACIA AND UPJOHN
LINCOMYCIN
X-GEN PHARMS INC
LINEZOLID
FOR SUSPENSION;ORAL
LINEZOLID
ROXANE
ZYVOX
+
PHARMACIA AND UPJOHN
SOLUTION;IV (INFUSION)
LINEZOLID
HOSPIRA INC
SANDOZ INC
600MG/300ML
200MG/100ML
600MG/300ML
TEVA PHARMS
600MG/300ML
LINEZOLID IN SODIUM CHLORIDE 0.9% IN
+
HOSPIRA INC
600MG/300ML
ZYVOX
PHARMACIA AND UPJOHN
200MG/100ML
200MG/100ML
400MG/200ML
+
600MG/300ML
TABLET;ORAL
LINEZOLID
TEVA PHARMS USA
600MG
ZYVOX
+
PHARMACIA AND UPJOHN
600MG
LISINOPRIL
TABLET;ORAL
LISINOPRIL
SUN PHARM INDS LTD
ZESTRIL
ALVOGEN IPCO SARL
LOMITAPIDE MESYLATE
CAPSULE;ORAL
JUXTAPID
AEGERION
LOMUSTINE
CAPSULE;ORAL
GLEOSTINE
CORDEN PHARMA
10
Jul
Jul
Jul
Jun
Apr
Apr
Apr
Apr
07,
16,
16,
27,
18,
18,
18,
18,
2015
2015
2015
2012
2000
2000
2000
2000
NEWA
NEWA
NEWA
CDFR
CTEC
CDFR
NEWA
NEWA
AB
AP
AP
>A>
>A>
>A>
>D>
>D>
>D>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
>A> AB
AB
AB
AB
October
2015
1 -56
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
@ J AND J CONSUMER INC
+
2MG
2MG
N 017690
N 017694
001
001
Jul CAHN
Jul CAHN
LOPINAVIR; RITONAVIR
CAPSULE;ORAL
KALETRA
@ ABBVIE
133.3MG;33.3MG
N 021226
Jun DISC
2MG/ML
4MG/ML
N 018140
N 018140
001
002
Jun CAHN
Jun CAHN
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
A 077396
A 077396
A 077396
A 077396
A 077396
A 077396
A 076045
A 076045
A 076045
001
002
003
001
002
003
001
002
003
Dec
Dec
Dec
Dec
Dec
Dec
Aug
Aug
Aug
13,
13,
13,
13,
13,
13,
29,
29,
29,
2006
2006
2006
2006
2006
2006
2001
2001
2001
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
A 203835
A 203835
A 203835
A 203030
A 203030
A 203030
A 091129
A 091129
A 091129
001
002
003
001
002
003
001
002
003
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
12,
12,
12,
14,
14,
14,
06,
06,
06,
2015
2015
2015
2015
2015
2015
2010
2010
2010
Jul
Jul
Jul
Oct
Oct
Oct
Feb
Feb
Feb
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
CMFD
CMFD
N 021316
N 021316
N 021316
N 021316
001
002
003
004
Jun
Jun
Jun
Jun
26,
26,
26,
26,
2002
2002
2002
2002
May
May
May
May
CAHN
CAHN
CAHN
CAHN
EQ 25MG BASE/ML
N 017658
001
Mar CAHN
EQ 50MG BASE/ML
N 018039
001
Mar CAHN
EQ
EQ
EQ
EQ
5MG BASE
10MG BASE
25MG BASE
50MG BASE
A 076868
A 076868
A 076868
A 076868
001
002
003
004
EQ
EQ
EQ
EQ
5MG BASE
10MG BASE
25MG BASE
50MG BASE
N 017525
N 017525
N 017525
N 017525
001
002
003
004
LORAZEPAM
INJECTABLE;INJECTION
ATIVAN
+
EUROHLTH INTL SARL
+
TABLET;ORAL
LORAZEPAM
ANI PHARMS INC
LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM
HETERO LABS LTD V
WATSON LABS
LOVASTATIN
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
@ COVIS PHARMA SARL
10MG
20MG
40MG
+
60MG
LOXAPINE HYDROCHLORIDE
CONCENTRATE;ORAL
LOXITANE C
@ ACTAVIS LABS UT INC
INJECTABLE;INJECTION
LOXITANE IM
@ ACTAVIS LABS UT INC
AB
AB
AB
AB
10
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXAPINE SUCCINATE
ELITE LABS INC
LOXITANE
@ ACTAVIS LABS UT INC
@
@
@
Aug
Aug
Aug
Aug
04,
04,
04,
04,
2005
2005
2005
2005
May
May
May
May
CAHN
CAHN
CAHN
CAHN
Mar
Mar
Mar
Mar
CAHN
CAHN
CAHN
CAHN
October
2015
1 -57
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
N 017525
N 017525
N 017525
006
007
008
Mar CAHN
Mar CAHN
Mar CAHN
8.5ML
N 021746
May DISC
Mar DISC
MAGNESIUM SULFATE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS
MAGNESIUM SULFATE
EXELA PHARMA SCS LLC
5GM/10ML (500MG/ML)
+
FRESENIUS KABI USA
5GM/10ML (500MG/ML)
+
HOSPIRA
5GM/10ML (500MG/ML)
HOSPIRA INC
10GM/20ML (500MG/ML)
A 206039
N 019316
A 075151
A 202411
001
001
001
001
Apr
Apr
Apr
Apr
MAGNESIUM SULFATE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS
MAGNESIUM SULFATE
+
FRESENIUS KABI USA
1GM/2ML (500MG/ML)
N 019316
TABLET;ORAL
LOXITANE
@ ACTAVIS LABS UT INC
@
@
LUCINACTANT
SUSPENSION;INTRATRACHEAL
SURFAXIN
@ DISCOVERY LABS
AP
AP
AP
10
Dec
Sep
Apr
May
18,
08,
25,
14,
2014
1986
2000
2015
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM
74GM,2.86GM,5.6GM
>A>
>A>
>A>
>A>
AA
AA
AA
CDFR
CPOT
CDFR
NEWA
Apr NEWA
Aug DISC
MANNITOL
INJECTABLE;INJECTION
MANNITOL 25%
@ IGI LABS INC
@
12.5GM/50ML
12.5GM/50ML
A 089239
A 089240
Mar CAHN
Mar CAHN
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
MECLIZINE HYDROCHLORIDE
@ ANI PHARMS INC
@
@ VINTAGE PHARMS
@
12.5MG
25MG
12.5MG
25MG
A 084975
A 084657
A 040179
A 040179
001
001
001 Jan 30, 1997
002 Jan 30, 1997
Aug
Aug
Jun
Jun
MELOXICAM
CAPSULE;ORAL
VIVLODEX
IROKO PHARMS LLC
+
5MG
10MG
N 207233
N 207233
Oct NEWA
Oct NEWA
N 022525
N 022525
N 022525
N 022525
001
002
003
004
Mar
Mar
Mar
Mar
A 202790
A 204033
Sep NEWA
Sep NEWA
N 021627
N 021627
Sep CFTG
Mar CAHN
MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NAMENDA XR
FOREST LABS LLC
7MG
14MG
21MG
+
28MG
SOLUTION;ORAL
MEMANTINE HYDROCHLORIDE
MACLEODS PHARMS LTD
2MG/ML
SILARX PHARMS INC
2MG/ML
NAMENDA
+
FOREST LABS LLC
2MG/ML
+
2MG/ML
Jun
Jun
Jun
Jun
21,
21,
21,
21,
2010
2010
2010
2010
CAHN
CAHN
DISC
DISC
CAHN
CAHN
CAHN
CAHN
>D>
>D> AB
AB
>D> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AP
AP
AP
2015
A 090058
A 090058
A 090058
A 090058
001
001
002
002
May
May
May
May
05,
05,
05,
05,
2010
2010
2010
2010
Oct
Mar
Oct
Mar
CTNA
CMFD
CTNA
CMFD
A 200891
A 200891
A 090041
A 090041
A 203175
A 203175
A 090048
A 090048
A 091585
A 091585
A 090051
A 090051
A 202840
A 202840
A 079225
A 079225
A 079225
A 079225
A 079225
A 079225
A 090058
A 090058
A 090052
A 090052
A 200155
A 200155
A 200022
A 200022
A 090043
A 090043
A 090073
A 090073
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
001
002
002
002
001
002
001
002
001
002
001
002
001
002
001
002
Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Sep
Sep
13,
13,
10,
10,
13,
13,
14,
14,
13,
13,
10,
10,
13,
13,
30,
30,
30,
30,
30,
30,
05,
05,
25,
25,
13,
13,
13,
13,
31,
31,
04,
04,
2015
2015
2015
2015
2015
2015
2010
2010
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2010
2010
2011
2011
2015
2015
2015
2015
2015
2015
2015
2015
Sep
Sep
Mar
Mar
Sep
Sep
Jun
Jun
Sep
Sep
Mar
Mar
Sep
Sep
Jun
Mar
Jan
Jun
Mar
Jan
Oct
Oct
May
May
Sep
Sep
Sep
Sep
Jul
Jul
Aug
Aug
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
CMFD
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
DISC
NEWA
CMFD
DISC
NEWA
CTNA
CTNA
CMFD
CMFD
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
N 021487
N 021487
Mar CAHN
Mar CAHN
MENOTROPINS (FSH;LH)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
REPRONEX
@ FERRING
75 IU/VIAL;75 IU/VIAL
N 021047
May DISC
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERIDINE HYDROCHLORIDE
EUROHLTH INTL SARL
25MG/ML
50MG/ML
75MG/ML
100MG/ML
@ IGI LABS INC
25MG/ML
@
50MG/ML
@
50MG/ML
@
50MG/ML
@
75MG/ML
@
100MG/ML
@
100MG/ML
@
100MG/ML
A 080445
A 080445
A 080445
A 080445
A 089781
A 089782
A 089783
A 089784
A 089785
A 089786
A 089787
A 089788
001
002
003
004
001
001
001
001
001
001
001
001
Feb
Feb
Feb
Feb
May
Mar
Mar
Mar
Mar
Mar
Mar
Mar
N 011730
001
5MG
5MG
10MG
10MG
MEMANTINE HYDROCHLORIDE
ALEMBIC PHARMS LTD
5MG
10MG
AMNEAL PHARMS
5MG
10MG
AUROBINDO PHARMA LTD 5MG
10MG
DR REDDYS LABS LTD
5MG
10MG
JUBILANT GENERICS
5MG
10MG
LUPIN LTD
5MG
10MG
MACLEODS PHARMS LTD
5MG
10MG
MYLAN PHARMS INC
5MG
@
5MG
5MG
10MG
@
10MG
10MG
SUN PHARMA GLOBAL
5MG
10MG
TEVA PHARMS
5MG
10MG
TORRENT PHARMS LTD
5MG
10MG
UNICHEM LABS LTD
5MG
10MG
UPSHER SMITH
5MG
10MG
WOCKHARDT LTD
5MG
10MG
NAMENDA
FOREST LABS LLC
5MG
+
10MG
1 -58
October
TABLET;ORAL
MEMANTINE
SUN PHARMA GLOBAL
10
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
31,
31,
31,
31,
31,
31,
31,
31,
1989
1989
1989
1989
1989
1989
1989
1989
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
Jun CAHN
10
AB
>D>
>D>
>A>
2015
N 202106
N 202106
Apr NEWA
Apr NEWA
N 022301
Jul CAHN
A 076841
Aug CAHN
N 021252
N 021252
Aug CAHN
Aug CAHN
N 019651
N 019651
Oct DISC
Oct DISC
0.1MG;2MG
N 013625
004
Mar CAHN
0.05MG;1MG
N 013625
002
Mar CAHN
0.05MG;1MG
N 016659
001
Mar CAHN
0.4%
0.6%
0.4%
0.6%
A 071786
A 070804
A 075586
A 075586
001
001
001
002
10MG/5ML
10MG/5ML
A 072761
A 073034
Apr CAHN
Apr CAHN
400MG
640MG
A 040486
N 022503
Feb NEWA
Jun NEWA
500MG/5ML
N 021591
Apr CAHN
A 204802
A 204802
Oct NEWA
Oct NEWA
N 022386
N 022386
Jun CFTG
Jun CFTG
A 200624
A 200624
Jun NEWA
Jun NEWA
MESALAMINE
CAPSULE, EXTENDED RELEASE;ORAL
APRISO
+
VALEANT PHARMS INTL
375MG
ENEMA;RECTAL
MESALAMINE
G AND W LABS INC
4GM/60ML
SUPPOSITORY;RECTAL
CANASA
@ FOREST LABS LLC
500MG
+
1GM
TABLET, DELAYED RELEASE;ORAL
ASACOL
+
WARNER CHILCOTT LLC
400MG
@
400MG
MESTRANOL; NORETHINDRONE
TABLET;ORAL-20
NORINYL
@ ACTAVIS LABS UT INC
TABLET;ORAL-21
NORINYL 1+50 21-DAY
@ ACTAVIS LABS UT INC
TABLET;ORAL-28
NORINYL 1+50 28-DAY
+
ACTAVIS LABS UT INC
METAPROTERENOL SULFATE
SOLUTION;INHALATION
METAPROTERENOL SULFATE
@ MYLAN SPECLT
@
@ WOCKHARDT
@
SYRUP;ORAL
METAPROTERENOL SULFATE
@ G AND W LABS INC
@
METAXALONE
TABLET;ORAL
METAXALONE
COREPHARMA
METFORMIN HYDROCHLORIDE
SOLUTION;ORAL
RIOMET
+
SUN PHARM INDS LTD
>A> AB
>A> AB
AB
AB
AB
AB
1 -59
October
MEROPENEM
POWDER;IV (INFUSION)
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN MEDICAL INC
500MG/VIAL
1GM/VIAL
Aug
Aug
May
May
05,
17,
30,
30,
1988
1987
2002
2002
Apr
Apr
Apr
Apr
DISC
DISC
DISC
DISC
2015
N 021410
N 021410
N 021410
N 021410
002
003
004
005
Oct
Oct
Aug
Aug
10,
10,
25,
25,
2002
2002
2003
2003
May
May
May
May
DISC
DISC
DISC
DISC
A 077337
A 077337
A 077337
A 077337
001
002
004
003
May
May
May
May
07,
07,
07,
07,
2014
2014
2014
2014
May
May
May
May
CTEC
CTEC
CRLD
CTEC
AA
AA
AA
AA
A 203502
A 203502
A 090065
A 090065
001
002
001
002
Aug
Aug
Aug
Aug
31,
31,
18,
18,
2015
2015
2015
2015
Aug
Aug
Aug
Aug
NEWA
NEWA
NEWA
NEWA
AB
AB
5MG
10MG
A 040734
A 040734
Mar CAHN
Mar CAHN
1GM/10ML (100MG/ML)
N 011790
001
Jun CAHN
METHADONE HYDROCHLORIDE
TABLET;ORAL
METHADONE HYDROCHLORIDE
AUROLIFE PHARMA LLC
5MG
10MG
COREPHARMA
5MG
10MG
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
HERITAGE PHARMA
1 -60
October
10
AP
METHOCARBAMOL
SOLUTION;IM-IV
ROBAXIN
+
EUROHLTH INTL SARL
AP
METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE PRESERVATIVE FREE
FRESENIUS KABI USA
EQ 25MG BASE/ML
A 040265
May CMFD
AB
METHOXSALEN
CAPSULE;ORAL
METHOXSALEN
ACTAVIS INC
A 202603
May NEWA
N 205831
N 205831
N 205831
N 205831
N 205831
N 205831
N 205831
001
002
003
004
005
006
007
Apr
Apr
Apr
Apr
Apr
Apr
Apr
17,
17,
17,
17,
17,
17,
17,
2015
2015
2015
2015
2015
2015
2015
Apr
Apr
Apr
Apr
Apr
Apr
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
A 203583
A 203583
A 203583
A 203583
A 203583
A 203583
001
002
003
004
005
006
Sep
Sep
Sep
Sep
Sep
Sep
29,
29,
29,
29,
29,
29,
2015
2015
2015
2015
2015
2015
Sep
Sep
Sep
Sep
Sep
Sep
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
N 021284
N 021284
Feb CRLD
Feb CRLD
A 204602
A 204602
Aug NEWA
Aug NEWA
A 207416
A 207416
A 207416
Sep NEWA
Sep NEWA
Sep NEWA
AB2
AB2
AB2
AB2
AB2
AB2
AB1
AA
AA
AB
AB
AB
10MG
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
APTENSIO XR
RHODES PHARMS
10MG
15MG
20MG
30MG
40MG
50MG
+
60MG
METHYLPHENIDATE HYDROCHLORIDE
MALLINCKRODT INC
10MG
20MG
30MG
40MG
50MG
60MG
RITALIN LA
NOVARTIS
40MG
+
60MG
SOLUTION;ORAL
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INC
5MG/5ML
10MG/5ML
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INC
5MG
10MG
20MG
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AP
AB
AB
AB
AB
>A>
>A>
>A>
>D>
>D>
>D>
2015
N 021475
N 021475
N 021475
Feb CFTG
Feb CFTG
Feb CFTG
A 204115
A 204115
A 204115
Feb NEWA
Feb NEWA
Feb NEWA
A 075629
May CTEC
A 207488
A 207488
May NEWA
May NEWA
10MG
A 204851
Sep NEWA
10MG
A 083976
001
Sep CTEC
1MG/ML
A 078950
Apr CAHN
37.5MG
75MG
A 076704
A 076704
Mar NEWA
Mar NEWA
1%
N 020743
Feb CAHN
1.3%
N 205223
Feb CAHN
1.3%
N 205223
Feb CTNA
500MG/100ML
CONTAINER
500MG/100ML
N 018907
Aug CAHN
A 078084
Apr CAHN
250MG
500MG
250MG
500MG
A 205245
A 205245
A 203974
A 203974
001
002
001
002
Sep
Sep
May
May
23,
23,
29,
29,
2015
2015
2015
2015
Sep
Sep
May
May
NEWA
NEWA
NEWA
NEWA
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
@
@
@ SANDOZ
@
@
150MG
200MG
250MG
150MG
200MG
250MG
A 074450
A 074450
A 074450
A 074450
A 074450
A 074450
001
002
003
001
002
003
May
May
May
May
May
May
16,
16,
16,
16,
16,
16,
1996
1996
1996
1996
1996
1996
Oct
Oct
Oct
Oct
Oct
Oct
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
MICONAZOLE
TABLET;BUCCAL
ORAVIG
+
DARA BIOSCIENCES
50MG
N 022404
2.5MG
5MG
+
10MG
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INC
2.5MG
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL
METHYLIN ER
MALLINCKRODT INC
10MG
METHYLPHENIDATE HYDROCHLORIDE
ABHAI
10MG
20MG
METHYLTESTOSTERONE
CAPSULE;ORAL
METHYLTESTOSTERONE
IMPAX LABS INC
TESTRED
+
VALEANT PHARM INTL
METOPROLOL TARTRATE
INJECTABLE;INJECTION
METOPROLOL TARTRATE
CLARIS PHARMASERVICE
TABLET;ORAL
METOPROLOL TARTRATE
MYLAN
METRONIDAZOLE
CREAM;TOPICAL
NORITATE
+
VALEANT PHARMS NORTH
GEL;VAGINAL
METRONIDAZOLE
+
ACTAVIS LABS UT INC
NUVESSA
+
ACTAVIS LABS UT INC
INJECTABLE;INJECTION
METRONIDAZOLE
@ EUROHLTH INTL SARL
METRONIDAZOLE IN PLASTIC
CLARIS PHARMASERVICE
TABLET;ORAL
METRONIDAZOLE
APPCO PHARMA LLC
AUROBINDO PHARMA LTD
1 -61
October
TABLET, CHEWABLE;ORAL
METHYLIN
MALLINCKRODT
10
Apr CAHN
AP
AP
AA
AB
AA
AB
AA
AB
AA
AB
AA
AB
AA
AB
AA
AP
AP
AP
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
MIGLITOL
TABLET;ORAL
GLYSET
PHARMACIA AND UPJOHN
+
+
MIGLITOL
ORIENT PHARMA CO LTD
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
BEDFORD
EUROHLTH INTL SARL
@
+
HIKMA FARMACEUTICA
2015
A 075637
A 075637
A 075243
A 075243
A 075263
A 078141
A 078511
A 078141
A 078511
001
002
001
002
001
001
001
002
002
A 076058
Apr CAHN
25MG
25MG
50MG
50MG
100MG
100MG
N 020682
N 020682
N 020682
N 020682
N 020682
N 020682
001
001
002
002
003
003
Dec
Dec
Dec
Dec
Dec
Dec
18,
18,
18,
18,
18,
18,
1996
1996
1996
1996
1996
1996
Mar
Feb
Mar
Feb
Mar
Feb
CTEC
CFTG
CTEC
CFTG
CTEC
CFTG
25MG
25MG
50MG
50MG
100MG
100MG
A 203965
A 203965
A 203965
A 203965
A 203965
A 203965
001
001
002
002
003
003
Feb
Feb
Feb
Feb
Feb
Feb
24,
24,
24,
24,
24,
24,
2015
2015
2015
2015
2015
2015
Mar
Feb
Mar
Feb
Mar
Feb
CTEC
NEWA
CTEC
NEWA
CTEC
NEWA
A 075660
A 075530
A 075852
A 077966
001
001
001
001
May
May
May
Dec
28,
28,
28,
03,
2002
2002
2002
2010
Jan
Jun
Sep
Jan
CRLD
CAHN
CAHN
CRLD
A 065062
A 065062
A 065062
A 065062
A 065062
A 065062
001
002
003
001
002
003
Nov
Nov
Nov
Nov
Nov
Nov
30,
30,
30,
30,
30,
30,
2000
2000
2000
2000
2000
2000
Apr
Apr
Apr
Jun
Jun
Jun
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
N 201922
N 201922
N 201922
N 201922
N 201922
001
002
003
004
005
Jul
Jul
Jul
Jul
Jul
11,
11,
11,
11,
11,
2012
2012
2012
2012
2012
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
A 065156
A 065156
A 065156
A 065156
A 065156
A 065156
001
002
003
001
002
003
Jan
Jan
Jan
Jan
Jan
Jan
06,
06,
06,
06,
06,
06,
2004
2004
2004
2004
2004
2004
Apr
Apr
Apr
Jun
Jun
Jun
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
A 090422
A 091118
A 091118
A 091118
003
001
004
005
Aug
Sep
Sep
Sep
13,
25,
25,
25,
2009
2014
2014
2014
Sep
Apr
Apr
Apr
CRLD
CAHN
CAHN
CAHN
EQ
EQ
EQ
EQ
1MG
1MG
1MG
1MG
BASE/ML
BASE/ML
BASE/ML
BASE/ML
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TORRENT PHARMA INC
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
CAPSULE, EXTENDED RELEASE;ORAL
XIMINO
@ SUN PHARM INDS LTD
EQ 45MG BASE
@
EQ 67.5MG BASE
@
EQ 90MG BASE
@
EQ 112.5MG BASE
@
EQ 135MG BASE
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TORRENT PHARMA INC
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
+
SANDOZ
EQ 135MG BASE
SUN PHARM INDS LTD
EQ 45MG BASE
EQ 80MG BASE
EQ 90MG BASE
1 -62
October
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
@ CLARIS PHARMASERVICE EQ 1MG BASE/ML
@
EQ 5MG BASE/ML
EUROHLTH INTL SARL
EQ 1MG BASE/ML
EQ 5MG BASE/ML
@ IGI LABS INC
EQ 5MG BASE/ML
@ WOCKHARDT
EQ 1MG BASE/ML
@
EQ 1MG BASE/ML
@
EQ 5MG BASE/ML
@
EQ 5MG BASE/ML
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 2MG BASE/ML
10
Oct
Oct
Jun
Jun
Jun
May
Nov
May
Nov
31,
31,
20,
20,
26,
30,
10,
30,
10,
2000
2000
2000
2000
2000
2008
2008
2008
2008
Apr
Apr
Jun
Jun
Apr
Mar
Mar
Mar
Mar
CAHN
CAHN
CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC
AB
AB
AB
AB
MIVACURIUM CHLORIDE
SOLUTION;INTRAVENOUS
MIVACRON
ABBVIE
+
2015
A 091118
A 091118
Apr CAHN
Apr CAHN
N 050808
N 050808
N 050808
Sep CRLD
Sep CRLD
Sep CRLD
Jan NEWA
Jan NEWA
A 090453
A 090453
A 090453
Mar NEWA
Mar NEWA
Mar NEWA
EQ 4MG BASE/PACKET
A 203438
Jul NEWA
EQ
EQ
EQ
EQ
10MG
10MG
10MG
10MG
A 203432
A 204604
A 201522
A 204290
001
001
001
001
Jul
Sep
Aug
Oct
31,
04,
03,
08,
2015
2015
2012
2015
Jul
Aug
Mar
Sep
NEWA
NEWA
CAHN
NEWA
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
A 203328
A 203328
A 205695
A 205695
A 204093
A 204093
A 203795
A 203795
A 200405
A 200405
A 203582
A 203582
001
002
001
002
001
002
001
002
001
002
001
002
Jul
Jul
Nov
Nov
May
May
Feb
Feb
Aug
Aug
Mar
Mar
31,
31,
05,
05,
22,
22,
27,
27,
03,
03,
12,
12,
2015
2015
2015
2015
2015
2015
2015
2015
2012
2012
2015
2015
Jul
Jul
Oct
Oct
May
May
Feb
Feb
Mar
Mar
Feb
Feb
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
N 021260
N 021260
N 021260
N 021260
N 021260
N 021260
001
005
002
006
003
004
Mar
Dec
Mar
Dec
Mar
Mar
20,
18,
20,
18,
20,
20,
2002
2008
2002
2008
2002
2002
Sep
Sep
Sep
Sep
Sep
Sep
DISC
DISC
DISC
DISC
DISC
DISC
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
008
001
004
009
009
002
005
010
010
006
003
011
012
007
Apr
Jul
Mar
Jul
Jul
Jul
Mar
Jul
Jul
Oct
Jul
Jul
Jul
Feb
20,
03,
09,
09,
09,
03,
09,
09,
09,
27,
03,
09,
09,
27,
2007
1996
2001
2012
2012
1996
2001
2012
2012
2006
1996
2012
2012
2007
Mar
Mar
Mar
May
Mar
Mar
Mar
May
Mar
Mar
Mar
Mar
Mar
Mar
CAHN
CAHN
CAHN
CTEC
CAHN
CAHN
CAHN
CTEC
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
MOLINDONE HYDROCHLORIDE
TABLET;ORAL
MOLINDONE HYDROCHLORIDE
COREPHARMA
5MG
10MG
+
25MG
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
MONTELUKAST SODIUM
GRANULE;ORAL
MONTELUKAST SODIUM
AJANTA PHARMA LTD
TABLET;ORAL
MONTELUKAST SODIUM
AJANTA PHARMA LTD
AMNEAL PHARMS
KREMERS URBAN PHARMS
UNICHEM LABS LTD
TABLET, CHEWABLE;ORAL
MONTELUKAST SODIUM
AJANTA PHARMA LTD
ANBISON LAB CO LTD
HETERO LABS LTD V
JUBILANT GENERICS
KREMERS URBAN PHARMS
MACLEODS PHARMS LTD
MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
AVINZA
@ KING PHARMS LLC
30MG
@
45MG
@
60MG
@
75MG
@
90MG
@
120MG
KADIAN
+
ACTAVIS LABS UT INC
10MG
20MG
30MG
40MG
40MG
50MG
60MG
70MG
70MG
80MG
+
100MG
130MG
150MG
+
200MG
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
1 -63
October
10
AB1
AB1
AP
AP
AP
AP
AP
AP
AP
AP
AA
AA
>A> AA
>A>
>A>
>A>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AT2
AT1
AT2
AT1
AT
AT1
AB
>D> AB
>A>
10
250MG
250MG
1 -64
October
2015
A 079040
A 079040
A 079040
A 079040
A 079040
A 079040
A 202718
A 202718
001
002
003
004
005
006
007
008
N 018565
N 018565
Jun CAHN
Jun CAHN
N 018565
N 018565
Jun CAHN
Jun CAHN
A 205758
A 205758
A 205758
N 202515
N 202515
N 202515
001
002
003
002
003
004
May
May
May
May
May
May
A 203518
A 203518
A 202310
May NEWA
May NEWA
Oct NEWA
N 206544
N 206544
N 206544
N 206544
001
002
003
004
Oct
Oct
Oct
Oct
02,
02,
02,
02,
2015
2015
2015
2015
Oct
Oct
Oct
Oct
NEWA
NEWA
NEWA
NEWA
A 203849
A 203849
A 203849
A 203849
A 203849
A 078761
A 078761
A 078761
A 078761
A 078761
001
002
003
004
005
001
002
003
004
005
Apr
Apr
Apr
Apr
Apr
May
May
May
May
May
06,
06,
06,
06,
06,
11,
11,
11,
11,
11,
2015
2015
2015
2015
2015
2012
2012
2012
2012
2012
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN
N 205572
Apr NEWA
N 022428
May CFTG
A 202867
A 204079
A 202525
A 202525
001
001
001
001
May
May
May
Feb
N 021598
May CTEC
A 204635
Aug NEWA
A 091315
A 091315
Oct DISC
Oct DISC
Jan
Jan
Jan
Jan
Jan
Jan
Jun
Jun
May
May
May
Nov
Nov
Nov
Sep
May
Mar
Mar
16,
16,
16,
16,
16,
16,
03,
03,
21,
21,
21,
14,
14,
14,
04,
28,
06,
06,
2013
2013
2013
2013
2013
2013
2015
2015
2015
2015
2015
2011
2011
2011
2014
2015
2015
2015
Sep
Sep
Sep
Sep
Sep
Sep
May
May
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
NEWA
NEWA
NEWA
NEWA
NEWA
CFTG
CFTG
CFTG
CTEC
NEWA
CTEC
NEWA
>D>
>D>
>D>
>D>
>D>
>A>
>A>
>A>
>A>
>A>
2015
20MG
40MG
80MG
120MG
160MG
20MG
40MG
80MG
120MG
160MG
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
40MG
80MG
A 201893
A 201893
Aug NEWA
Aug NEWA
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@
10MG/ML
10MG/ML
10MG/ML
20MG/ML
20MG/ML
20MG/ML
A 072070
A 072071
A 072072
A 072073
A 072074
A 072075
001
001
001
001
001
001
Mar
Mar
Mar
Mar
Mar
Mar
NALMEFENE HYDROCHLORIDE
INJECTABLE;INJECTION
REVEX
@ EUROHLTH INTL SARL
@
EQ 0.1MG BASE/ML
EQ 1MG BASE/ML
N 020459
N 020459
Jun CAHN
Jun CAHN
0.4MG/ML
A 070299
Mar CAHN
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
1MG/ML
1MG/ML
1MG/ML
A 072082
A 072083
A 072084
A 072085
A 072086
A 072087
A 072088
A 072089
A 072090
A 072091
A 072092
A 072093
001
001
001
001
001
001
001
001
001
001
001
001
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
0.02MG/ML
0.4MG/ML
1MG/ML
N 016636
N 016636
N 016636
002
001
003 Jun 14, 1982
Aug CAHN
Aug CAHN
Aug CAHN
AB
A 075523
Apr CAHN
AB
NAPROXEN
SUSPENSION;ORAL
NAPROSYN
+
PEDIAPHARM INC
N 018965
Apr CAHN
N 020353
N 020353
N 020353
Oct CAHN
Oct CAHN
Oct CAHN
AB
AB
AB
+
@
@
AB
AB
AB
AB
AB
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
@ EUROHLTH INTL SARL
NALOXONE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@
@
@
@
@
@
@
NARCAN
@ ADAPT
@
@
>D> AB
>D> AB
>D>
25MG/ML
NAPROXEN SODIUM
TABLET, EXTENDED RELEASE;ORAL
NAPRELAN
ALMATICA PHARMA INC
EQ 375MG BASE
EQ 500MG BASE
+
EQ 750MG BASE
1 -65
October
NADOLOL
TABLET;ORAL
CORGARD
KING PHARMS
10
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
10,
10,
10,
10,
10,
10,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
>A> AB
>A> AB
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
2015
N 020353
N 020353
N 020353
Oct CAHN
Oct CAHN
Oct CAHN
N 021926
Jun NEWA
NEBIVOLOL HYDROCHLORIDE
TABLET;ORAL
NEBIVOLOL HYDROCHLORIDE
@ ALKEM LABS LTD
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@ AMERIGEN PHARMS LTD
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@ INDCHEMIE HEALTH
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ
A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828
001
001
002
002
003
003
004
004
001
001
002
002
003
003
004
004
001
001
002
002
003
003
004
004
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
24,
24,
24,
24,
24,
24,
24,
24,
16,
16,
16,
16,
16,
16,
16,
16,
29,
29,
29,
29,
29,
29,
29,
29,
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Mar
Apr
Mar
Apr
Mar
Apr
Mar
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
A 076072
A 076072
A 076072
A 076072
A 076072
A 076409
A 076409
A 076409
A 076409
A 076409
001
002
003
004
005
001
002
003
004
005
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
250MG/50ML (5MG/ML)
N 021877
Mar CAHN
NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS
NEOSTIGMINE METHYLSULFATE
FRESENIUS KABI USA
5MG/10ML (0.5MG/ML)
10MG/10ML (1MG/ML)
N 203629
N 203629
Jan NEWA
Jan NEWA
NEVIRAPINE
TABLET, EXTENDED RELEASE;ORAL
NEVIRAPINE
ALVOGEN MALTA
100MG
100MG
400MG
ALVOGEN PINE BROOK
400MG
400MG
CIPLA LTD
400MG
A 204621
A 204621
A 204621
A 204621
A 204621
A 206448
002
002
001
001
001
001
Oct
Oct
Oct
Oct
Jun
Oct
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
@
@
@
@
SUN PHARM INDS LTD
NELARABINE
INJECTABLE;IV (INFUSION)
ARRANON
+
NOVARTIS PHARMS CORP
>A>
>A>
>A>
>D>
AB
AB
AB
AB
AB
>A> AB
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
1 -66
October
10
Nov
Nov
Jul
Jul
Jul
Oct
09,
09,
10,
10,
10,
15,
2015
2015
2015
2015
2015
2015
NEWA
CAHN
CAHN
CAHN
NEWA
NEWA
10
October
2015
1 -67
A 206271
Oct NEWA
>D>
>A> AB
N 201152
N 201152
Oct CFTG
Oct CFTG
AB
AB
NIACIN
TABLET, EXTENDED RELEASE;ORAL
NIACIN
AMNEAL PHARMS
500MG
1GM
A 203578
A 203578
Jul NEWA
Jul NEWA
A 202644
A 202644
Mar CAHN
Mar CAHN
A 075289
A 075289
Aug CAHN
Aug CAHN
>A> AB
AB
AB
AB2
AB2
AB
AB
NIFEDIPINE
CAPSULE;ORAL
NIFEDIPINE
HERITAGE PHARMA
10MG
20MG
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
VALEANT PHARMS NORTH
30MG
60MG
NILUTAMIDE
TABLET;ORAL
NILANDRON
@ CONCORDIA PHARMS INC
+
50MG
150MG
N 020169
N 020169
Apr CAHN
Apr CAHN
NIMODIPINE
CAPSULE;ORAL
NIMODIPINE
+
BANNER LIFE SCIENCES
SOFGEN PHARMS
30MG
30MG
A 076740
A 201832
Jan CAHN
Jul NEWA
NINTEDANIB ESYLATE
CAPSULE;ORAL
OFEV
BOEHRINGER INGELHEIM
+
EQ 100MG BASE
EQ 150MG BASE
N 205832
N 205832
Mar CAIN
Mar CAIN
NITRIC OXIDE
GAS;INHALATION
INOMAX
@ INO
100PPM
N 020845
Jun DISC
N 016620
N 016620
N 016620
N 016620
N 016620
N 016620
N 016620
003
003
001
002
003
001
002
Oct
Jun
Oct
Oct
Oct
Oct
Oct
A 091095
A 091095
A 091095
Jun NEWA
Jun NEWA
Jun NEWA
A 202250
Jun NEWA
AB
AB
AB
NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACRODANTIN
ALVOGEN INC
25MG
25MG
50MG
+
100MG
ALVOGEN MALTA
25MG
50MG
+
100MG
NITROFURANTOIN
ACTAVIS LABS FL INC
25MG
50MG
100MG
AB
>D> AB
AB
>D> AB
>D> AB
>A> AB
>A> AB
>A> AB
CAHN
CTEC
CAHN
CAHN
CAHN
CAHN
CAHN
October
2015
1 -68
NORETHINDRONE
TABLET;ORAL-28
NOR-QD
AB1
+
ACTAVIS LABS UT INC
0.35MG
N 017060
001
Mar CAHN
NORGESTREL
TABLET;ORAL
OVRETTE
@ LABORATOIRE HRA
0.075MG
N 017031
001
Jun CAHN
100,000 UNITS/GM
A 061966
001
Jun CMFD
100,000 UNITS/ML
100,000 UNITS/ML
A 062349
A 062776
Apr CAHN
Apr CAHN
A 062367
Mar CMFD
A 062733
Mar CMFD
A 076093
Jul CMFD
A 202295
A 202295
A 202295
A 202295
A 202295
A 202295
A 077301
001
002
003
004
005
006
001
Oct
Oct
Oct
Oct
Oct
Oct
Apr
20,
20,
20,
20,
20,
20,
29,
2015
2015
2015
2015
2015
2015
2015
Oct
Oct
Oct
Oct
Oct
Oct
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
A 203044
A 203044
A 203044
A 203044
A 202937
A 202937
A 202937
A 202937
001
002
003
004
001
002
003
004
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar
20,
20,
20,
20,
02,
02,
02,
02,
2015
2015
2015
2015
2015
2015
2015
2015
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
N 206162
Jan CTNA
N 206756
May NEWA
A 090848
Jun NEWA
N 021545
Jun CFTG
AT
AA
NYSTATIN
CREAM;TOPICAL
NYSTATIN
G AND W LABS INC
SUSPENSION;ORAL
NYSTATIN
G AND W LABS INC
@
AT
AB
OFLOXACIN
TABLET;ORAL
OFLOXACIN
LARKEN LABS
AT
>A>
>A>
>A>
>A>
>A>
>A>
10
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
400MG
OLANZAPINE
TABLET;ORAL
OLANZAPINE
ALKEM LABS LTD
2.5MG
5MG
7.5MG
10MG
15MG
20MG
IVAX PHARMS INC
20MG
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
MACLEODS PHARMS LTD
5MG
10MG
15MG
20MG
ORCHID HLTHCARE
5MG
10MG
15MG
20MG
OLAPARIB
CAPSULE;ORAL
LYNPARZA
ASTRAZENECA PHARMS
50MG
AT
AT
OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OLOPATADINE HYDROCHLORIDE
BARR LABS INC
EQ 0.2% BASE
PATADAY
+
ALCON PHARMS LTD
EQ 0.2% BASE
AB
AB
AB
AB
2015
N 206276
Jan NEWA
N 207931
N 207931
Aug CMS1
Jul NEWA
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
OMEPRAZOLE
AUROBINDO PHARMA USA
10MG
20MG
40MG
LUPIN LTD
40MG
A 203270
A 203270
A 203270
A 202384
001
002
003
001
Aug
Aug
Aug
Aug
AB
AB
A 078602
A 078602
Apr CAHN
Apr CAHN
AB
AB
N 020781
N 020781
Mar CAHN
Mar CAHN
A 206846
A 078288
A 077365
Jun NEWA
Apr CAHN
Jun CAHN
A 078287
A 077541
A 078014
Apr CAHN
Jun CAHN
Jan DISC
N 020007
Mar CAHN
N 020007
Mar CAHN
N 020605
Mar CAHN
N 020103
N 020103
N 020103
Mar CAHN
Mar CAHN
Mar CAHN
30MG/ML
30MG/ML
N 013055
N 013055
001
001
Apr CAHN
Mar DISC
30MG/ML
A 040484
Mar CRLD
OXACILLIN SODIUM
CAPSULE;ORAL
OXACILLIN SODIUM
@ ANI PHARMS INC
@
EQ 250MG BASE
EQ 500MG BASE
A 062222
A 062222
001
002
Aug CAHN
Aug CAHN
OXANDROLONE
TABLET;ORAL
OXANDRIN
GEMINI LABS LLC
+
2.5MG
10MG
N 013718
N 013718
001
002 Nov 05, 2001
Aug CAHN
Aug CAHN
ONDANSETRON
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
SUN PHARM INDS LTD
4MG
8MG
ZOFRAN ODT
NOVARTIS PHARMS CORP
4MG
+
8MG
AB
AB
AB
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
ACCORD HLTHCARE
EQ 2MG BASE/ML
CLARIS PHARMASERVICE
EQ 2MG BASE/ML
EUROHLTH INTL SARL
EQ 2MG BASE/ML
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
CLARIS PHARMASERVICE
EQ 2MG BASE/ML
EUROHLTH INTL SARL
EQ 2MG BASE/ML
@ TARO PHARMS IRELAND
EQ 2MG BASE/ML
ZOFRAN
+
NOVARTIS PHARMS CORP
EQ 2MG BASE/ML
ZOFRAN PRESERVATIVE FREE
+
NOVARTIS PHARMS CORP EQ 2MG BASE/ML
SOLUTION;ORAL
ZOFRAN
+
NOVARTIS PHARMS CORP EQ 4MG BASE/5ML
TABLET;ORAL
ZOFRAN
NOVARTIS PHARMS CORP EQ 4MG BASE
EQ 8MG BASE
+
EQ 24MG BASE
AP
ORPHENADRINE CITRATE
INJECTABLE;INJECTION
NORFLEX
@ IGI LABS INC
@ MEDICIS
ORPHENADRINE CITRATE
+
AKORN
AP
AP
AP
AP
AP
AP
AP
AA
AB
AB
1 -69
October
SOLUTION/DROPS;OPHTHALMIC
PAZEO
+
ALCON RES LTD
EQ 0.7% BASE
10
Aug
Aug
Aug
Aug
19,
19,
19,
25,
2015
2015
2015
2015
NEWA
NEWA
NEWA
NEWA
AB
AB
OXCARBAZEPINE
SUSPENSION;ORAL
OXCARBAZEPINE
SUN PHARM INDS LTD
OXYBUTYNIN CHLORIDE
GEL;TRANSDERMAL
GELNIQUE
+
ACTAVIS LABS UT INC
AB
AB
AA
AA
AA
2015
A 078734
Apr CAHN
N 021351
Mar CAHN
N 202513
Mar CAHN
10%(100MG/PACKET)
N 022204
Mar CAHN
5MG
5MG
A 202773
A 204752
Aug NEWA
Aug NEWA
5MG/5ML
100MG/5ML
5MG/5ML
A 204979
A 204603
A 206456
May NEWA
Apr NEWA
Jun NEWA
5MG
7.5MG
5MG
7.5MG
5MG
7.5MG
N 202080
N 202080
N 202080
N 202080
N 202080
N 202080
001
002
001
002
001
002
Jun
Jun
Jun
Jun
Jun
Jun
17,
17,
17,
17,
17,
17,
2011
2011
2011
2011
2011
2011
Mar
Mar
May
May
Jul
Jul
CTNA
CTNA
CAHN
CAHN
CAHN
CAHN
A 076636
A 202662
A 202662
A 202662
A 202662
A 077712
A 077712
003
001
002
003
004
004
005
Apr
Sep
Sep
Sep
Sep
Apr
Apr
07,
22,
22,
22,
22,
13,
13,
2015
2015
2015
2015
2015
2015
2015
Mar
Sep
Sep
Sep
Sep
Mar
Mar
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
A 203506
A 203506
A 203506
A 203506
A 203506
A 203506
A 203506
001
002
003
004
005
006
007
Apr
Apr
Apr
Apr
Apr
Apr
Apr
24,
24,
24,
24,
24,
24,
24,
2015
2015
2015
2015
2015
2015
2015
Apr
Apr
Apr
Apr
Apr
Apr
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
OXYBUTYNIN
FILM, EXTENDED RELEASE;TRANSDERMAL
OXYTROL
+
ACTAVIS LABS UT INC
3.9MG/24HR
GEL, METERED;TRANSDERMAL
GELNIQUE 3%
+
ACTAVIS LABS UT INC
3%
OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE HYDROCHLORIDE
AVANTHI INC
NOVEL LABS INC
SOLUTION;ORAL
OXYCODONE HYDROCHLORIDE
ANI PHARMS INC
NOVEL LABS INC
WOCKHARDT BIO AG
TABLET;ORAL
OXAYDO
ACURA PHARMS INC
EGALET LTD
EGALET US INC
OXYCODONE HYDROCHLORIDE
ACTAVIS ELIZABETH
5MG
EPIC PHARMA LLC
5MG
10MG
15MG
30MG
VINTAGE PHARMS
10MG
20MG
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
OXYMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OXYMORPHONE HYDROCHLORIDE
SUN PHARM INDS LTD
5MG
7.5MG
10MG
15MG
20MG
30MG
40MG
AP
AP
OXYTOCIN
INJECTABLE;INJECTION
OXYTOCIN
+
EUROHLTH INTL SARL
+
PALBOCICLIB
CAPSULE;ORAL
IBRANCE
PFIZER INC
+
1 -70
October
300MG/5ML
10
001
002 Jan 10, 2007
Feb CAHN
Feb CAHN
75MG
100MG
125MG
Feb NEWA
Feb NEWA
Feb NEWA
N 207103
N 207103
N 207103
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AP
AP
AP
AP
2015
N 021999
N 021999
N 021999
N 021999
006
001
002
003
Aug
Dec
Dec
Dec
26,
19,
19,
19,
2008
2006
2006
2006
Jul
Jul
Jul
Jul
CFTG
CFTG
CFTG
CFTG
A 202645
A 202645
A 202645
A 202645
A 203802
A 203802
A 203802
A 203802
001
002
003
004
001
002
003
004
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
03,
03,
03,
03,
24,
24,
24,
24,
2015
2015
2015
2015
2015
2015
2015
2015
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
INVEGA TRINZA
JANSSEN PHARMS
273MG/0.875ML (273MG/0.875ML)
410MG/1.315ML (311.79MG/ML)
546MG/1.75ML (312MG/ML)
+
819MG/2.625ML (312MG/ML)
N 207946
N 207946
N 207946
N 207946
001
002
003
004
May
May
May
May
18,
18,
18,
18,
2015
2015
2015
2015
May
May
May
May
NEWA
NEWA
NEWA
NEWA
PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS
ALOXI
+
HELSINN HLTHCARE
N 021372
Sep CFTG
N 021372
Sep CFTG
A 202521
Sep NEWA
A 090713
Sep NEWA
A 090713
Sep NEWA
1MG/ML
2MG/ML
2MG/ML
2MG/ML
A 072210
A 072211
A 072212
A 072213
001
001
001
001
Mar
Mar
Mar
Mar
10MG
15MG
20MG
N 205353
N 205353
N 205353
Feb NEWA
Feb NEWA
Feb NEWA
N 205353
N 205353
N 205353
N 205353
N 205353
N 205353
001
001
002
002
003
003
Mar
Mar
Mar
Mar
Mar
Mar
A 090296
Jun NEWA
A 078281
Mar CAHN
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
JANSSEN PHARMS
1.5MG
3MG
+
6MG
9MG
PALIPERIDONE
ACTAVIS LABS FL INC
1.5MG
3MG
6MG
9MG
MYLAN PHARMS INC
1.5MG
3MG
6MG
9MG
PANOBINOSTAT
CAPSULE;ORAL
FARYDAK
NOVARTIS PHARMS CORP
+
PANOBINOSTAT LACTATE
CAPSULE;ORAL
FARYDAK
NOVARTIS PHARMS CORP
+
+
AB
EQ
EQ
EQ
EQ
EQ
EQ
10MG
10MG
15MG
15MG
20MG
20MG
BASE
BASE
BASE
BASE
BASE
BASE
PANTOPRAZOLE SODIUM
INJECTABLE;IV (INFUSION)
PANTOPRAZOLE SODIUM
SANDOZ INC
EQ 40MG BASE/VIAL
TABLET, DELAYED RELEASE;ORAL
PANTOPRAZOLE SODIUM
KREMERS URBAN PHARMS EQ 20MG BASE
1 -71
October
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
@ IGI LABS INC
@
@
@
AP
10
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
31,
31,
31,
31,
23,
23,
23,
23,
23,
23,
1988
1988
1988
1988
2015
2015
2015
2015
2015
2015
CAHN
CAHN
CAHN
CAHN
CAIN
CPOT
CAIN
CPOT
CAIN
CPOT
2015
A 078281
A 200794
A 200794
Mar CAHN
Apr CAHN
Apr CAHN
1MCG
2MCG
4MCG
A 202539
A 202539
A 202539
Jan CAHN
Jan CAHN
Jan CAHN
EQ 8.4GM BASE/PACKET
EQ 16.8GM BASE/PACKET
EQ 25.2GM BASE/PACKET
N 205739
N 205739
N 205739
Oct NEWA
Oct NEWA
Oct NEWA
EQ 200MG BASE
EQ 400MG BASE
EQ 400MG BASE
N 022465
N 022465
N 022465
Mar CAHN
Aug DISC
Mar CAHN
A 075028
Feb CAHN
A 088021
Jan DISC
N 018074
001
Jan CTEC
AB
PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIBENZYLINE
+
CONCORDIA PHARMS INC 10MG
N 008708
001
Jun CAHN
AA
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
PHENTERMINE HYDROCHLORIDE
MIKAH PHARMA LLC
37.5MG
A 040228
Jun CMFD
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE
+
AKORN INC
2.5%
2.5%
+
10%
10%
+
PARAGON BIOTECK
2.5%
N 207926
N 207926
N 207926
N 207926
N 203510
001
001
002
002
001
Sep
Jan
Sep
Jan
Sep
AA
A 088761
Jul CAHN
A 040759
A 040732
Jun DISC
Jun DISC
AB
PHENYTOIN SODIUM
CAPSULE;ORAL
EXTENDED PHENYTOIN SODIUM
@ WOCKHARDT
30MG EXTENDED
@ WOCKHARDT USA
100MG EXTENDED
PHENYTOIN SODIUM
AUROBINDO PHARMA LTD 100MG EXTENDED
A 204309
May NEWA
AB
AB
AB
AB
AB
AB
>A>
>A>
>A>
>A>
>A>
>A>
PARICALCITOL
CAPSULE;ORAL
PARICALCITOL
BANNER LIFE SCIENCES
AB
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
VALEANT PHARMS
400MG
PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
BONTRIL
@ VALEANT
105MG
PHENDIMETRAZINE TARTRATE
+
SANDOZ
105MG
1 -72
October
10
Jan
Jan
Jan
Jan
Mar
15,
15,
15,
15,
21,
2015
2015
2015
2015
2013
CRLD
NEWA
CRLD
NEWA
CRLD
October
2015
1 -73
50MG/ML
A 084307
001
Feb CAHN
1MG/0.5ML
10MG/ML
N 012223
N 012223
002
001
Apr CAHN
Apr CAHN
N 018796
Aug DISC
A 076746
Mar CAHN
1MG
2MG
N 017473
N 017473
Sep CFTG
Sep CFTG
1MG
2MG
A 204521
A 204521
Sep NEWA
Sep NEWA
5MG
5MG
5MG
10MG
10MG
10MG
A 073661
A 073687
A 074123
A 073661
A 073687
A 074123
001
001
001
002
002
002
Apr
Apr
Apr
Apr
Apr
Apr
PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
@ MEDICIS
EQ 0.2MG BASE/INH
N 020014
Jan DISC
PIRFENIDONE
CAPSULE;ORAL
ESBRIET
+
GENENTECH INC
267MG
N 022535
Feb CAHN
10MG
20MG
A 074116
A 074118
May CAHN
May CAHN
0.5%
N 020529
Feb CAHN
0.5%
N 019795
Jan CAHN
0.5%
A 090184
May CAHN
A 064211
Jan CAHN
AP
INJECTABLE;INJECTION
PHENYTOIN SODIUM
+
EUROHLTH INTL SARL
PHYTONADIONE
INJECTABLE;INJECTION
AQUAMEPHYTON
@ IGI LABS INC
@
AB
AB
AB
AB
AB
PILOCARPINE HYDROCHLORIDE
GEL;OPHTHALMIC
PILOPINE HS
@ ALCON
4%
TABLET;ORAL
PILOCARPINE HYDROCHLORIDE
ELAN PHARMA INTL LTD 5MG
PIMOZIDE
TABLET;ORAL
ORAP
TEVA
+
PIMOZIDE
PAR PHARM
PINDOLOL
TABLET;ORAL
PINDOLOL
@ G AND W LABS INC
@
@
@
@
@
AB
AB
10
PIROXICAM
CAPSULE;ORAL
PIROXICAM
MYLAN PHARMS INC
AT
PODOFILOX
GEL;TOPICAL
CONDYLOX
+
ACTAVIS LABS UT INC
SOLUTION;TOPICAL
CONDYLOX
+
ACTAVIS LABS UT INC
PODOFILOX
BAUSCH AND LOMB INC
AT
AT
Oct
Feb
Apr
Oct
Feb
Apr
31,
26,
17,
31,
26,
17,
1993
1993
1997
1993
1993
1997
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
PONATINIB HYDROCHLORIDE
TABLET;ORAL
ICLUSIG
ARIAD
AB
AB
AB1
AB2
AB2
>A> AB2
>A> AB2
EQ 30MG BASE
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
KLOR-CON
UPSHER SMITH
8MEQ
10MEQ
FOR SOLUTION;ORAL
POTASSIUM CHLORIDE
PHARMA RES SOFTWARE
20MEQ
TABLET, EXTENDED RELEASE;ORAL
POTASSIUM CHLORIDE
ADARE PHARMS INC
20MEQ
MYLAN PHARMS INC
8MEQ
10MEQ
PADDOCK LLC
8MEQ
10MEQ
10
1 -74
October
2015
N 203469
Apr NEWA
A 203106
A 203106
Jun NEWA
Jun NEWA
N 208019
Aug NEWA
A 076368
A 204662
A 204662
A 205993
A 205993
001
001
002
001
002
Jul
Feb
Feb
Oct
Oct
A 090781
Aug NEWA
A 203354
A 203354
A 203354
A 203354
A 203354
001
002
003
004
005
Jul
Jul
Jul
Jul
Jul
Aug
Aug
Aug
Nov
Nov
18,
21,
21,
05,
05,
2004
2014
2014
2015
2015
CAHN
CPOT
CPOT
NEWA
NEWA
AB
AB
AB
AB
AB
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK GENERICS
0.75MG
TABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
DR REDDYS LABS LTD
0.375MG
0.75MG
1.5MG
3MG
4.5MG
AB
PREDNICARBATE
OINTMENT;TOPICAL
DERMATOP
+
VALEANT PHARMS NORTH
0.1%
N 019568
Apr CAHN
PREDNISONE
TABLET;ORAL
PREDNISONE
@ HIKMA PHARMS
1MG
A 040890
Aug DISC
25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG
N 021446
N 021446
N 021446
N 021446
N 021446
N 021446
N 021446
N 021446
001
002
003
004
005
006
007
008
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
A 089219
A 089221
Jun CAHN
Jun CAHN
A 089369
A 089370
A 089371
Jun CAHN
Jun CAHN
Jun CAHN
AB
PREGABALIN
CAPSULE;ORAL
LYRICA
PF PRISM CV
PROCAINAMIDE HYDROCHLORIDE
CAPSULE;ORAL
PROCAINAMIDE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
250MG
@
500MG
TABLET, EXTENDED RELEASE;ORAL
PROCAINAMIDE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
250MG
@
500MG
@
750MG
Aug
Aug
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
07,
07,
07,
07,
07,
30,
30,
30,
30,
30,
30,
30,
30,
2015
2015
2015
2015
2015
2004
2004
2004
2004
2004
2004
2004
2004
NEWA
NEWA
NEWA
NEWA
NEWA
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
AP
AB
AB
AO
PROGESTERONE
CAPSULE;ORAL
PROGESTERONE
BANNER LIFE SCIENCES
GEL;VAGINAL
CRINONE
ACTAVIS LABS UT INC
+
INJECTABLE;INJECTION
PROGESTERONE
+
ACTAVIS LABS UT INC
2015
A 089903
Feb CAHN
100MG
200MG
A 200900
A 200900
Jan CAHN
Jan CAHN
4%
8%
N 020701
N 020701
Feb CAHN
Feb CAHN
50MG/ML
N 017362
002
Mar CAHN
A 083312
A 083312
001
002
Jun CAHN
Jun CAHN
N 010926
N 010926
002
001
Apr CAHN
Apr CAHN
A 040673
A 040673
A 040673
Mar CAHN
Mar CAHN
Mar CAHN
A 202688
A 202688
A 202688
Aug NEWA
Aug NEWA
Aug NEWA
A 040512
A 040512
A 205650
Aug CAHN
Aug CAHN
Jun NEWA
AB
AB
AB
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROMETHAZINE HYDROCHLORIDE
+
EUROHLTH INTL SARL
25MG/ML
+
50MG/ML
SUPPOSITORY;RECTAL
PHENERGAN
@ DELCOR ASSET CORP
12.5MG
@
25MG
TABLET;ORAL
PROMETHAZINE HYDROCHLORIDE
HERITAGE PHARMA
12.5MG
25MG
50MG
AB
AB
AB
PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPAFENONE HYDROCHLORIDE
WATSON LABS INC
225MG
325MG
425MG
AP
AP
AB
AB
AB
AB
AB
AB
AB
1 -75
October
PROCHLORPERAZINE EDISYLATE
INJECTABLE;INJECTION
PROCHLORPERAZINE EDISYLATE
+
EUROHLTH INTL SARL
EQ 5MG BASE/ML
10
PYRIDOSTIGMINE BROMIDE
TABLET;ORAL
PYRIDOSTIGMINE BROMIDE
@ ANI PHARMS INC
30MG
@
60MG
ZYDUS PHARMS USA INC
60MG
TABLET, EXTENDED RELEASE;ORAL
MESTINON
+
VALEANT PHARMS LLC
180MG
PYRIDOSTIGMINE BROMIDE
ALVOGEN INC
180MG
IMPAX LABS INC
180MG
N 011665
001
Jun CFTG
A 204737
A 203184
Jun NEWA
Aug NEWA
PYRIMETHAMINE
TABLET;ORAL
DARAPRIM
+
TURING PHARMS AG
25MG
N 008578
001
Aug CAHN
QUAZEPAM
TABLET;ORAL
DORAL
@ SCIECURE PHARMA INC
15MG
N 018708
Jun DISC
EQ
EQ
EQ
EQ
N 020639
N 020639
N 020639
N 020639
001
007
002
004
May
May
May
May
QUETIAPINE FUMARATE
TABLET;ORAL
SEROQUEL
+
ASTRAZENECA PHARMS
25MG BASE
50MG BASE
100MG BASE
150MG BASE
Sep
Oct
Sep
Dec
26,
04,
26,
20,
1997
2005
1997
1998
CAHN
CAHN
CAHN
CAHN
10
1 -76
October
2015
N 020639
N 020639
N 020639
May CAHN
May CAHN
May CAHN
A 076607
A 076607
A 076607
A 076607
001
002
003
004
Apr
Apr
Apr
Apr
A 088431
Jun CAHN
A 083640
A 085632
001
001
Jun CAHN
Jun CAHN
A 040045
Apr CAHN
A 203729
A 203112
A 204372
Jun NEWA
Apr NEWA
Jul NEWA
TABLET;ORAL
SEROQUEL
AB
AB
AB
AB
AB
AB
AB
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
SUN PHARM INDS LTD
EQ
EQ
EQ
EQ
5MG BASE
10MG BASE
20MG BASE
40MG BASE
QUINIDINE GLUCONATE
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE GLUCONATE
@ CYCLE PHARMS LTD
324MG
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
@ CYCLE PHARMS LTD
200MG
@
300MG
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE SULFATE
+
G AND W LABS INC
300MG
Dec
Dec
Dec
Dec
15,
15,
15,
15,
2004
2004
2004
2004
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
QUININE SULFATE
CAPSULE;ORAL
QUININE SULFATE
AMNEAL PHARMS
LUPIN LTD
RICONPHARMA LLC
AB
RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
RABEPRAZOLE SODIUM
AMNEAL PHARMS
20MG
A 204179
Jul NEWA
AB
AB
RALOXIFENE HYDROCHLORIDE
TABLET;ORAL
RALOXIFENE HYDROCHLORIDE
AUROBINDO PHARMA LTD 60MG
WATSON LABS INC
60MG
A 204310
A 200825
Aug NEWA
Jan NEWA
AB
RAMELTEON
TABLET;ORAL
RAMELTEON
ACTAVIS LABS FL INC
A 091610
Aug NEWA
N 019090
Jun CAHN
A 075439
A 075439
Apr CAHN
Apr CAHN
A 091517
A 091517
A 091517
Apr NEWA
Apr NEWA
Apr NEWA
AP
AB
AB
AB
324MG
324MG
324MG
8MG
RANITIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
ZANTAC
+
CONCORDIA PHARMS INC
EQ 25MG BASE/ML
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
@ SUN PHARM INDS LTD
EQ 150MG BASE
@
EQ 300MG BASE
REPAGLINIDE
TABLET;ORAL
REPAGLINIDE
STANDARD CHEM PHARM
0.5MG
1MG
2MG
RIBAVIRIN
CAPSULE;ORAL
REBETOL
@ MERCK SHARP DOHME
200MG
10
1 -77
October
2015
N 020903
Jun DISC
N 022560
May CFTG
A 203217
May NEWA
Apr
Apr
Apr
Apr
Apr
AB
RISEDRONATE SODIUM
TABLET, DELAYED RELEASE;ORAL
ATELVIA
+
WARNER CHILCOTT LLC
35MG
RISEDRONATE SODIUM
TEVA PHARMS USA
35MG
AB
AB
AB
AB
AB
RISPERIDONE
TABLET, ORALLY DISINTEGRATING;ORAL
RISPERIDONE
SUN PHARM INDS LTD
0.5MG
1MG
2MG
3MG
4MG
A 077542
A 077542
A 077542
A 078474
A 078474
001
002
003
001
002
RIVAROXABAN
TABLET;ORAL
XARELTO
JANSSEN PHARMS
N 022406
Apr CRLD
N 022083
N 022083
N 022083
Aug CFTG
Aug CFTG
Aug CFTG
A 204403
A 204403
A 204403
A 204403
A 204403
A 204403
001
002
003
001
002
003
Sep
Sep
Aug
Sep
Sep
Aug
03,
03,
31,
03,
03,
31,
2015
2015
2015
2015
2015
2015
Aug
Aug
Aug
Aug
Aug
Aug
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
A 090879
A 090879
A 090879
A 090879
001
002
003
004
Jun
Jun
Jun
Jun
10,
10,
10,
10,
2015
2015
2015
2015
May
May
May
May
NEWA
NEWA
NEWA
NEWA
A 203334
A 203334
Oct NEWA
Oct NEWA
50MG/5ML (10MG/ML)
100MG/10ML (10MG/ML)
A 091458
A 091458
Aug CAHN
Aug CAHN
ROFLUMILAST
TABLET;ORAL
DALIRESP
+
ASTRAZENECA PHARMS
500MCG
N 022522
Mar CAHN
ROLAPITANT HYDROCHLORIDE
TABLET;ORAL
VARUBI
+
TESARO INC
EQ 90MG BASE
N 206500
Sep NEWA
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AP
AP
10MG
RIVASTIGMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
EXELON
NOVARTIS
4.6MG/24HR
+
9.5MG/24HR
13.3MG/24HR
RIVASTIGMINE
ALVOGEN INC
4.6MG/24HR
9.5MG/24HR
13.3MG/24HR
ALVOGEN PINE BROOK
4.6MG/24HR
9.5MG/24HR
13.3MG/24HR
RIVASTIGMINE TARTRATE
CAPSULE;ORAL
RIVASTIGMINE TARTRATE
ORCHID HLTHCARE
EQ
EQ
EQ
EQ
1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE
RIZATRIPTAN BENZOATE
TABLET, ORALLY DISINTEGRATING;ORAL
RIZATRIPTAN BENZOATE
JUBILANT GENERICS
EQ 5MG BASE
EQ 10MG BASE
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ROCURONIUM BROMIDE
SAGENT PHARMS
Aug
Aug
Aug
Aug
Aug
06,
06,
06,
06,
06,
2010
2010
2010
2010
2010
CAHN
CAHN
CAHN
CAHN
CAHN
AB
AB
AB
AB
AB
AB
AB
SACUBITRIL; VALSARTAN
TABLET;ORAL
ENTRESTO
NOVARTIS PHARMS CORP
+
SAPROPTERIN DIHYDROCHLORIDE
POWDER;ORAL
KUVAN
BIOMARIN PHARM
>A>
AB
AB
AB
2015
A 077460
A 077460
A 077460
A 077460
A 077460
A 077460
A 077460
001
002
003
004
005
006
007
24MG;26MG
49MG;51MG
97MG;103MG
N 207620
N 207620
N 207620
Jul NEWA
Jul NEWA
Jul NEWA
500MG/PACKET
N 205065
Oct NEWA
A 078830
A 078830
Mar CAHN
Jan NEWA
N 017874
001
Jan CFTG
A 074537
A 074744
A 074756
Apr CAHN
Apr CAHN
Apr CAHN
A 077864
A 077864
A 077864
A 077977
A 077977
A 077977
A 077977
A 077977
001
002
003
001
002
003
004
005
May
May
May
Apr
Apr
Apr
Apr
Apr
100%
A 203793
Oct NEWA
N 022473
Mar CFTG
A 203988
Mar NEWA
4MG
8MG
N 022206
N 022206
Mar CAHN
Mar CAHN
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
SCOPOLAMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
SCOPOLAMINE
PERRIGO PHARMS CO
1MG/72HR
PERRIGO R AND D
1MG/72HR
TRANSDERM SCOP
+
NOVARTIS
1MG/72HR
SELEGILINE HYDROCHLORIDE
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
@ G AND W LABS INC
5MG
@
5MG
@
5MG
AB
AB
AB
SERTRALINE HYDROCHLORIDE
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
@ HIKMA PHARMS
@
@
SUN PHARM INDS LTD
>A> AN
SEVOFLURANE
LIQUID;INHALATION
SEVOFLURANE
SHANGHAI HENGRUI
AP
SILDENAFIL CITRATE
SOLUTION;INTRAVENOUS
REVATIO
+
PFIZER
AP
SILDENAFIL CITRATE
AUROBINDO PHARMA LTD
SILODOSIN
CAPSULE;ORAL
RAPAFLO
+
ACTAVIS LABS UT INC
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
150MG BASE
200MG BASE
1 -78
October
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
G AND W LABS INC
EQ
EQ
EQ
EQ
EQ
EQ
EQ
10
May
May
May
May
May
May
May
Aug
Aug
Aug
Feb
Feb
Feb
Feb
Feb
05,
05,
05,
05,
05,
05,
19,
10,
10,
10,
06,
06,
06,
06,
06,
2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2007
2007
2007
2007
2007
Apr
Apr
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
DISC
DISC
DISC
CAHN
CAHN
CAHN
CAHN
CAHN
>A>
>A>
>A>
>A>
>A>
>D>
>D>
>D>
>D>
>D>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AP
AB
>A> AP
AP
AP
AP
AP
AP
AP
>A> AP
AP
AA
AA
2015
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 076285
A 076285
A 076285
A 076285
A 076285
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
A 201850
Feb CAHN
A 201833
Feb CAHN
N 021569
N 021569
N 021569
N 021569
001
002
001
002
Feb
Feb
Feb
Feb
A 078215
Jun CAHN
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
A 203777
A 203780
A 204530
A 203592
A 204517
A 204542
A 203912
A 203968
A 204497
001
001
001
001
001
001
001
001
001
Oct
Jul
Jul
Aug
Jul
Feb
Apr
Oct
Apr
100uCi
200uCi
400uCi
N 018671
N 018671
N 018671
Apr CAHN
Apr CAHN
Apr CAHN
N 016692
001
Sep DISC
N 020004
Sep CTEC
A 040905
Mar NEWA
N 011287
001
Apr CAHN
BLU CARIBE
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
SODIUM CHLORIDE
INJECTABLE;INJECTION
SODIUM CHLORIDE 0.9%
EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9%
EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+
LIEBEL-FLARSHEIM
45MG/50ML (9MG/ML)
112.5MG/125ML (9MG/ML)
+
405MG/50ML (9MG/ML)
1012.5MG/125ML (9MG/ML)
SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
1.87GM/100ML
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
B BRAUN
1.87GM/100ML
AA
1 -79
October
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
BIOCON LIMITED
10
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jul
Jul
Jul
Jul
Oct
Jul
Jul
Aug
Jul
Feb
Apr
Oct
Apr
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
23,
27,
27,
27,
27,
19,
30,
29,
18,
21,
27,
22,
23,
20,
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2015
2015
2015
2015
2015
2015
2015
2015
2015
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CPOT
CPOT
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
2015
20MG/2ML (10MG/ML)
A 040541
Jul CRLD
30MG/3ML
N 021148
Jan NEWA
30MG/3ML
30MG/3ML
30MG/3ML
N 021148
N 021148
N 021148
Jul DISC
Mar CMFD
Jan DISC
5MG/VIAL
10MG/VIAL
10MG/VIAL
N 020168
N 020168
N 020168
Jun DISC
Jun DISC
Mar CTEC
10MG/2ML (5MG/ML)
N 020522
Jun DISC
5MG/2ML (2.5MG/ML)
10MG/2ML (5MG/ML)
20MG/2ML (10MG/ML)
N 020522
N 020522
N 020522
Jun CTNA
Jun NEWA
Jun CTNA
20MG/2ML (10MG/ML)
N 020522
Jun NEWA
5MG/VIAL
10MG/VIAL
10MG/VIAL
N 019774
N 019774
N 019774
Mar CTNA
Apr CRLD
Mar NEWA
EQ 200MG BASE
N 205266
Jul NEWA
150MG/10ML (15MG/ML)
N 022306
Apr CAHN
80MG
120MG
160MG
240MG
320MG
N 019865
N 019865
N 019865
N 019865
N 019865
001
005
002
003
004
Mar
Mar
Mar
Mar
Mar
A 206369
Aug NEWA
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
QUELICIN PRESERVATIVE FREE
@ HOSPIRA
100MG/ML
N 008845
004
Jun DISC
AB
SUCRALFATE
TABLET;ORAL
SUCRALFATE
MYLAN PHARMS INC
1GM
A 074415
May CAHN
AP
SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTANIL CITRATE
EUROHLTH INTL SARL
EQ 0.05MG BASE/ML
A 074413
Jun CAHN
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
NORDITROPIN FLEXPRO
NOVO NORDISK INC
NORDITROPIN NORDIFLEX
@ NOVO NORDISK INC
@
NUTROPIN
@ GENENTECH
@
BX
BX
BX
BX
+
NUTROPIN AQ
@ GENENTECH
NUTROPIN AQ NUSPIN
+
GENENTECH
+
+
NUTROPIN AQ PEN
+
GENENTECH
ZOMACTON
+
FERRING
+
SONIDEGIB PHOSPHATE
CAPSULE;ORAL
ODOMZO
+
NOVARTIS PHARMS CORP
SOTALOL HYDROCHLORIDE
SOLUTION;INTRAVENOUS
SOTALOL HYDROCHLORIDE
+
ALTATHERA PHARMS LLC
TABLET;ORAL
BETAPACE
AB1
COVIS PHARMA SARL
AB1
AB1
+
AB1
@
AP
1 -80
October
10
Oct
Apr
Oct
Oct
Oct
30,
20,
30,
30,
30,
1992
1994
1992
1992
1992
CAHN
CAHN
CAHN
CAHN
CAHN
AB
>D>
>D> AT
>A>
>D> AT
>A>
AT
>A>
>D>
AB
AB
AB
2015
10%
N 019931
Mar CAHN
10%
10%
A 080021
A 080021
001
001
Oct DISC
Oct DISC
10%
10%
A 080029
A 080029
001
001
Oct CRLD
Oct CRLD
10%
A 040215
Mar CMFD
SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
@ ANI PHARMS INC
200MG/5ML;40MG/5ML
A 070028
Jul CAHN
SULFANILAMIDE
CREAM;VAGINAL
SULFANILAMIDE
@ G AND W LABS INC
15%
A 088718
Apr CAHN
SULFISOXAZOLE
TABLET;ORAL
SULFISOXAZOLE
@ ANI PHARMS INC
@ IVAX SUB TEVA PHARMS
500MG
500MG
A 080142
A 080142
001
001
Oct CAHN
Oct CAHN
SULINDAC
TABLET;ORAL
SULINDAC
@ ANI PHARMS INC
@
150MG
200MG
A 072972
A 072973
Aug CAHN
Aug CAHN
EQ
EQ
EQ
EQ
EQ
EQ
A 076976
A 076976
A 076976
A 076554
A 076554
A 076572
001
002
003
001
002
001
Sep
Sep
Sep
Apr
Apr
Apr
N 206406
N 206406
N 206406
Jul NEWA
Jul NEWA
Jul NEWA
N 203794
May CAHN
N 022304
N 022304
N 022304
May CAHN
May CAHN
May CAHN
N 200533
N 200533
N 200533
N 200533
N 200533
001
002
003
004
005
May
May
May
May
May
SUMATRIPTAN SUCCINATE
TABLET;ORAL
SUMATRIPTAN SUCCINATE
@ SANDOZ
@
@
SUN PHARM INDS LTD
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
TACROLIMUS
TABLET, EXTENDED RELEASE;ORAL
ENVARSUS XR
VELOXIS PHARMS INC
EQ 0.75MG BASE
EQ 1MG BASE
+
EQ 4MG BASE
TAPENTADOL HYDROCHLORIDE
SOLUTION;ORAL
NUCYNTA
+
DEPOMED INC
TABLET;ORAL
NUCYNTA
DEPOMED INC
EQ 20MG BASE/ML
EQ 50MG BASE
EQ 75MG BASE
+
EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL
NUCYNTA ER
DEPOMED INC
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
+
EQ 250MG BASE
1 -81
October
SULFACETAMIDE SODIUM
LOTION;TOPICAL
KLARON
+
VALEANT PHARMS NORTH
OINTMENT;OPHTHALMIC
CETAMIDE
+
ALCON
@
SULFACETAMIDE SODIUM
PERRIGO CO TENNESSEE
+
SOLUTION/DROPS;OPHTHALMIC
SULFACETAMIDE SODIUM
AKORN
10
Aug
Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug
Aug
Aug
10,
10,
10,
10,
10,
09,
25,
25,
25,
25,
25,
2009
2009
2009
2009
2009
2009
2011
2011
2011
2011
2011
DISC
DISC
DISC
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
TEDIZOLID PHOSPHATE
POWDER;IV (INFUSION)
SIVEXTRO
+
CUBIST PHARMS LLC
TABLET;ORAL
SIVEXTRO
+
CUBIST PHARMS LLC
TELAPREVIR
TABLET;ORAL
INCIVEK
@ VERTEX PHARMS
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
TELMISARTAN
TABLET;ORAL
TELMISARTAN
AMNEAL PHARMS
INVENTIA HLTHCARE
TEMAZEPAM
CAPSULE;ORAL
TEMAZEPAM
VINTAGE PHARMS
TEMOZOLOMIDE
CAPSULE;ORAL
TEMOZOLOMIDE
AMNEAL PHARMS
TERBINAFINE
GEL;TOPICAL
LAMISIL
@ GLAXOSMITHKLINE CONS
2015
200MG/VIAL
N 205436
Sep CAHN
200MG
N 205435
Sep CAHN
375MG
N 201917
Jan DISC
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
A 204415
A 204415
A 204415
A 206511
A 206511
A 206511
A 205150
A 205150
A 205150
001
002
003
001
002
003
001
002
003
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
08,
08,
08,
03,
03,
03,
30,
30,
30,
2015
2015
2015
2015
2015
2015
2015
2015
2015
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
7.5MG
15MG
22.5MG
30MG
A 201781
A 201781
A 201781
A 201781
001
002
003
004
Jun
Jun
Jun
Jun
04,
04,
04,
04,
2015
2015
2015
2015
May
May
May
May
NEWA
NEWA
NEWA
NEWA
5MG
20MG
100MG
140MG
180MG
250MG
A 203691
A 203691
A 203691
A 203691
A 203691
A 203691
001
002
003
004
005
006
May
May
May
May
May
May
08,
08,
08,
08,
08,
08,
2015
2015
2015
2015
2015
2015
Apr
Apr
Apr
Apr
Apr
Apr
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
A 091612
Mar NEWA
N 021356
Mar CFTG
N 020846
Aug CAHN
N 020749
Aug CAHN
A 078229
Feb DISC
A 077553
Sep CMFD
1%
TERBINAFINE HYDROCHLORIDE
SOLUTION;TOPICAL
LAMISIL
@ GLAXOSMITHKLINE CONS
1%
TABLET;ORAL
TERBINAFINE HYDROCHLORIDE
@ WOCKHARDT
EQ 250MG BASE
AB
TERCONAZOLE
SUPPOSITORY;VAGINAL
TERCONAZOLE
TARO
80MG
1 -82
October
10
TESTOSTERONE
GEL;TRANSDERMAL
ANDROGEL
AB1
ABBVIE
AB1
+
TESTIM
AB2
+
AUXILIUM PHARMS
TESTOSTERONE
@ ACTAVIS LABS UT INC
@
AB1
AB1
BX
ANI PHARMS INC
BX
AB1
PAR PHARM
AB1
AB1
PERRIGO ISRAEL
AB1
VOGELXO
AB2
UPSHER SMITH
GEL, METERED;TRANSDERMAL
ANDROGEL
AB
+
ABBVIE
FORTESTA
AB
+
ENDO PHARMS
TESTOSTERONE
AB
ACTAVIS LABS UT INC
AB
AB
PERRIGO ISRAEL
AB
AB
TETRABENAZINE
TABLET;ORAL
TETRABENAZINE
SUN PHARMA GLOBAL
XENAZINE
VALEANT PHARMS NORTH
AB
AB
AB
AB
AB
+
+
October
1 -83
2015
25MG/2.5GM PACKET
50MG/5GM PACKET
N 021015
001 Feb 28, 2000
N 021015
002 Feb 28, 2000
Jan CTEC
Jan CTEC
50MG/5GM PACKET
N 021454
001 Oct 31, 2002
Jan CTEC
1% (2.5GM/PACKET)
1% (5GM/PACKET)
25MG/2.5GM PACKET
50MG/5GM PACKET
25MG/2.5GM PACKET
50MG/5GM PACKET
25MG/2.5GM PACKET
50MG/5GM PACKET
25MG/2.5GM PACKET
50MG/5GM PACKET
A 076737
A 076737
A 076737
A 076737
N 202763
N 202763
A 076744
A 076744
N 203098
N 203098
Mar
Mar
Jul
Jul
May
May
Aug
Aug
Jan
Jan
50MG/5GM PACKET
N 204399
002 Jun 04, 2014
Jan CTEC
N 022309
001 Apr 29, 2011
Jul CFTG
10MG/0.5GM ACTUATION
N 021463
001 Dec 29, 2010
Jul CFTG
10MG/0.5GM ACTUATION
12.5MG/1.25GM ACTUATION
A 204571
001 Aug 05, 2015
A 076737
003 Mar 09, 2015
A 204268
001 Aug 04, 2015
Jul NEWA
Aug NEWA
Jul NEWA
12.5MG
25MG
A 206129
001 Aug 17, 2015
A 206129
002 Aug 17, 2015
Aug NEWA
Aug NEWA
12.5MG
12.5MG
25MG
25MG
N 021894
N 021894
N 021894
N 021894
Aug
Feb
Aug
Feb
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
ACHROMYCIN V
+
HERITAGE PHARMS INC
500MG
TETRACYCLINE HYDROCHLORIDE
@ CHARTWELL CIENCA
250MG
@
500MG
@ IVAX SUB TEVA PHARMS
250MG
@
500MG
THEOPHYLLINE
TABLET;ORAL
THEOLAIR
@ MEDICIS
125MG
@
250MG
TABLET, EXTENDED RELEASE;ORAL
THEOPHYLLINE
MYLAN PHARMS INC
400MG
+
600MG
THIOTEPA
INJECTABLE;INJECTION
THIOTEPA
+
EUROHLTH INTL SARL
10
15MG/VIAL
001
002
001
002
001
002
001
002
002
003
001
001
002
002
Jan
Jan
Jan
Jan
Feb
Feb
May
May
Jan
Jan
Aug
Aug
Aug
Aug
27,
27,
27,
27,
14,
14,
23,
23,
31,
31,
15,
15,
15,
15,
2006
2006
2006
2006
2012
2012
2007
2007
2013
2013
2008
2008
2008
2008
CAHN
CAHN
CMFD
CMFD
CAHN
CAHN
CMFD
CMFD
CTEC
CTEC
CFTG
CAHN
CFTG
CAHN
N 050278
001
Apr CRLD
A 062752
A 062752
A 060704
A 060704
Sep
Sep
Apr
Apr
CAHN
CAHN
DISC
DISC
A 086399
001
A 086399
002
Mar DISC
Mar DISC
A 040595
001 Apr 21, 2006
A 040560
002 Apr 21, 2006
May CAHN
May CAHN
A 075547
001 Apr 02, 2001
May CRLD
2015
60MG
N 022433
Sep NEWA
AP
50MG/VIAL
A 091620
May NEWA
AP
50MG/VIAL
N 021821
May CFTG
BASE
N 021516
Apr CFTG
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
A 074466
A 074516
A 074262
A 204936
A 074776
A 077259
A 075163
A 074747
A 078771
001
001
001
001
001
002
001
001
002
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
BASE
N 018086
002
Apr CTEC
A 203808
A 203808
Jul NEWA
Jul NEWA
TIOTROPIUM BROMIDE
SPRAY, METERED;INHALATION
SPIRIVA RESPIMAT
BOEHRINGER INGELHEIM EQ 0.00125MG BASE/INH
N 021936
Sep NEWA
N 207981
N 207981
Sep NEWA
Sep NEWA
N 205433
Feb CTEC
A 205501
Jun NEWA
N 050541
001
Mar CAHN
A 063119
A 063120
A 063121
A 063122
001
001
001
001
Oct
Oct
Oct
Oct
31,
31,
31,
31,
1994
1994
1994
1994
Mar
Mar
Mar
Mar
CAHN
CAHN
CAHN
CAHN
A 065120
A 065120
A 063116
A 063116
001
001
001
001
Nov
Nov
May
May
29,
29,
18,
18,
2002
2002
1992
1992
Jul
Jul
Jul
Jul
CTEC
CRLD
DISC
CTNA
TIGECYCLINE
INJECTABLE;IV (INFUSION)
TIGECYCLINE
SANDOZ INC
TYGACIL
+
PF PRISM CV
TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
ISTALOL
AT2
+
BAUSCH AND LOMB
EQ 0.5%
TIMOLOL MALEATE
AT1
AKORN
EQ 0.5%
AT1
EQ 0.5%
AT1
ALCON RES LTD
EQ 0.5%
AT2
APOTEX INC
EQ 0.5%
AT1
BAUSCH AND LOMB
EQ 0.5%
AT1
FDC LTD
EQ 0.5%
AT1
HI TECH PHARMA
EQ 0.5%
AT1
PACIFIC PHARMA
EQ 0.5%
AT1
WOCKHARDT
EQ 0.5%
TIMOPTIC
AT1
+
ATON
EQ 0.5%
AB
AB
AN
AN
AT
AP
AP
TINIDAZOLE
TABLET;ORAL
TINIDAZOLE
EDENBRIDGE PHARMS
250MG
500MG
TOBRAMYCIN
SOLUTION;INHALATION
KITABIS PAK
PULMOFLOW INC
300MG/5ML
TOBRAMYCIN
AMNEAL PHARMS
300MG/5ML
SOLUTION/DROPS;OPHTHALMIC
TOBREX
+
ALCON LABS INC
0.3%
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
TOBRAMYCIN SULFATE
@ IGI LABS INC
EQ 10MG BASE/ML
@
EQ 40MG BASE/ML
@
EQ 40MG BASE/ML
@
EQ 40MG BASE/ML
TOBRAMYCIN SULFATE (PHARMACY BULK)
+
FRESENIUS KABI USA
EQ 40MG BASE/ML
+
EQ 40MG BASE/ML
@ HOSPIRA
EQ 40MG BASE/ML
EQ 40MG BASE/ML
1 -84
October
TICAGRELOR
TABLET;ORAL
BRILINTA
ASTRAZENECA LP
10
Mar
Mar
Apr
Apr
Mar
Apr
Sep
Mar
Sep
25,
25,
28,
17,
25,
30,
10,
25,
28,
1997
1997
1995
2015
1997
2008
2002
1997
2009
CTEC
CTEC
CTEC
NEWA
CTEC
CTEC
CTEC
CTEC
CTEC
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
@ G AND W LABS INC
@
@
AB
AB
TOLCAPONE
TABLET;ORAL
TASMAR
+
VALEANT PHARMS LLC
TOLCAPONE
PAR PHARM INC
TOLMETIN SODIUM
TABLET;ORAL
TOLMETIN SODIUM
@ G AND W LABS INC
@
AB
AB
AB
AB
AB
AB
AB
AB
AB
TOPIRAMATE
TABLET;ORAL
TOPIRAMATE
SUN PHARM INDS LTD
@ WOCKHARDT USA
@
@
@
TOPIRAMATE
@ HIKMA PHARMS
@
@
@
AP
AP
TOPOTECAN HYDROCHLORIDE
CAPSULE;ORAL
HYCAMTIN
NOVARTIS PHARMS CORP
+
INJECTABLE;INJECTION
HYCAMTIN
+
NOVARTIS PHARMS CORP
TOPOTECAN HYDROCHLORIDE
CHEM WERTH INC
TORSEMIDE
INJECTABLE;INJECTION
TORSEMIDE
@ EUROHLTH INTL SARL
@
@ LUITPOLD
@
2015
100MG
250MG
500MG
N 018894
N 018894
N 018894
Apr CAHN
Apr CAHN
Apr CAHN
100MG
N 020697
Mar CFTG
100MG
A 204584
Mar NEWA
EQ 600MG BASE
EQ 600MG BASE
A 074399
A 074729
May CAHN
Apr CAHN
A 203016
A 203016
Jul NEWA
Jul NEWA
A 077006
A 077006
A 203409
A 203409
001
002
001
002
Feb
Feb
Aug
Aug
23,
23,
31,
31,
2015
2015
2015
2015
Feb
Feb
Aug
Aug
NEWA
NEWA
NEWA
NEWA
25MG
100MG
200MG
25MG
50MG
100MG
200MG
A 076327
A 076327
A 076327
A 090353
A 090353
A 090353
A 090353
001
002
003
001
002
003
004
Mar
Mar
Mar
Sep
Sep
Sep
Sep
27,
27,
27,
01,
01,
01,
01,
2009
2009
2009
2010
2010
2010
2010
Apr
Apr
Apr
Apr
Apr
Apr
Apr
CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC
25MG
50MG
100MG
200MG
A 091185
A 091185
A 091185
A 091185
001
002
003
004
Nov
Nov
Nov
Nov
25,
25,
25,
25,
2013
2013
2013
2013
May
May
May
May
DISC
DISC
DISC
DISC
EQ 0.25MG BASE
EQ 1MG BASE
N 020981
N 020981
Mar CAHN
Mar CAHN
EQ 4MG BASE/VIAL
N 020671
Mar CAHN
EQ 4MG BASE/VIAL
A 201166
May CAHN
20MG/2ML
50MG/5ML
20MG/2ML
50MG/5ML
A 078007
A 078007
A 090656
A 090656
001
002
001
002
Jan
Jan
Jan
Jan
(10MG/ML)
(10MG/ML)
(10MG/ML)
(10MG/ML)
1 -85
October
TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
TOLTERODINE TARTRATE
TORRENT PHARMS LTD
2MG
4MG
TABLET;ORAL
TOLTERODINE TARTRATE
IVAX SUB TEVA PHARMS 1MG
2MG
MACLEODS PHARMS LTD
1MG
2MG
10
Jun
Jun
Apr
Apr
11,
11,
21,
21,
2008
2008
2010
2010
DISC
DISC
DISC
DISC
>A>
>A>
>A>
>A>
TRABECTEDIN
POWDER;IV (INFUSION)
YONDELIS
+
JANSSEN PRODS
2015
N 207953
Oct NEWA
A 205702
Sep NEWA
A 204421
A 204421
A 204421
Oct NEWA
Oct NEWA
Oct NEWA
N 204114
N 204114
N 204114
Mar CAHN
Mar CAHN
Mar CAHN
100MG/ML
A 091596
Apr CMFD
650MG
A 205133
Sep NEWA
EQ 10MG BASE
N 012342
Jun CAHN
N 204822
Jul DISC
N 021994
Jun CTEC
A 203431
Jun NEWA
50MG
100MG
150MG
300MG
N 018207
N 018207
N 018207
N 018207
001
002
003 Mar 25, 1985
004 Nov 07, 1988
May
May
May
May
0.02%
0.05%
N 021108
N 019963
Apr CAHN
Apr CAHN
0.1%
N 017340
001
Apr CAHN
0.05%
N 022070
Jul CTEC
0.05%
A 207955
Jul NEWA
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB
MACLEODS PHARMS LTD
50MG
TABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDE
>A> AB1
AUROBINDO PHARMA LTD 100MG
>A> AB1
200MG
>A> AB1
300MG
TRAMETINIB DIMETHYL SULFOXIDE
TABLET;ORAL
MEKINIST
NOVARTIS PHARMS CORP EQ 0.5MG NON-SOLVATED PARENT
EQ 1MG NON-SOLVATED PARENT
+
EQ 2MG NON-SOLVATED PARENT
AB
TRANEXAMIC ACID
INJECTABLE;INJECTION
TRANEXAMIC ACID
FRESENIUS KABI USA
TABLET;ORAL
TRANEXAMIC ACID
MYLAN
AB
TRANYLCYPROMINE SULFATE
TABLET;ORAL
PARNATE
+
CONCORDIA PHARMS INC
AP
AT
AT
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
IZBA
@ ALCON LABS INC
0.003%
TRAVATAN Z
+
ALCON PHARMS LTD
0.004%
TRAVOPROST
APOTEX INC
0.004%
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
DESYREL
@ PRAGMA PHARMS LLC
@
@
@
TRETINOIN
CREAM;TOPICAL
RENOVA
+
VALEANT PHARMS NORTH
AB2
+
RETIN-A
AB
+
VALEANT PHARMS NORTH
GEL;TOPICAL
ATRALIN
AB
+
DOW PHARM
TRETINOIN
AB
SPEAR PHARMS INC
1 -86
October
1MG/VIAL
10
CAHN
CAHN
CAHN
CAHN
AT
AT
AT
AT
AT
AT
AT
AT
AT
AT
AT
AT
2015
A 089797
A 089798
Apr CMFD
Apr CMFD
A 088042
A 088042
Mar NEWA
Mar NEWA
A 089129
Mar CMFD
N 011600
N 011600
003
001
Mar CMFD
Mar CMFD
A 089795
A 089796
Aug CMFD
Aug CMFD
N 012104
N 012104
001
001
Mar CFTG
Aug CAHN
A 205782
Mar NEWA
50MG
100MG
N 013174
N 013174
001
002
Apr CAHN
Apr CAHN
EQ 50MG BASE
EQ 100MG BASE
N 016792
N 016792
002
003 Sep 15, 1982
Jun CRLD
Jun CRLD
A 088821
Jul CAHN
TRIPTORELIN PAMOATE
INJECTABLE;INTRAMUSCULAR
TRELSTAR
+
ACTAVIS LABS UT INC
+
+
N 020715
N 021288
N 022437
Jan CAHN
Jan CAHN
Jan CAHN
N 022103
May DISC
A 091289
A 091289
A 091635
Jun CRLD
May CRLD
Apr NEWA
N 021595
May DISC
A 091575
A 091575
Jun CRLD
May CRLD
N 021214
N 021214
May CAHN
Jan CAHN
TRIAMTERENE
CAPSULE;ORAL
DYRENIUM
CONCORDIA PHARMS INC
+
AB
AB
AB
AB
AB
AB
AB
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
SURMONTIL
+
ODYSSEY PHARMS
EQ 3.75MG BASE/VIAL
EQ 11.25MG BASE/VIAL
EQ 22.5MG BASE/VIAL
TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
SANCTURA XR
@ ALLERGAN
60MG
TROSPIUM CHLORIDE
ACTAVIS LABS FL INC
60MG
+
60MG
SANDOZ INC
60MG
TABLET;ORAL
SANCTURA
@ ALLERGAN
20MG
TROSPIUM CHLORIDE
GLENMARK GENERICS
20MG
+
20MG
UNOPROSTONE ISOPROPYL
SOLUTION/DROPS;OPHTHALMIC
RESCULA
+
R-TECH UENO LTD
0.15%
+
SUCAMPO PHARMA LLC
0.15%
1 -87
October
TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIAMCINOLONE ACETONIDE
G AND W LABS
0.025%
0.1%
TRIDERM
CROWN LABS
0.025%
0.5%
LOTION;TOPICAL
TRIAMCINOLONE ACETONIDE
G AND W LABS INC
0.1%
OINTMENT;TOPICAL
KENALOG
DELCOR ASSET CORP
0.025%
0.1%
TRIAMCINOLONE ACETONIDE
G AND W LABS
0.025%
0.1%
SPRAY;TOPICAL
KENALOG
+
RANBAXY
0.147MG/GM
+
SUN PHARM INDS LTD
0.147MG/GM
TRIAMCINOLONE ACETONIDE
PERRIGO UK FINCO
0.147MG/GM
10
10
October
2015
1 -88
URIDINE TRIACETATE
GRANULE;ORAL
XURIDEN
+
WELLSTAT THERAP
2GM/PACKET
N 208169
Sep NEWA
AB
URSODIOL
CAPSULE;ORAL
ACTIGALL
@ ACTAVIS LABS UT INC
+
150MG
300MG
N 019594
N 019594
Mar CAHN
Mar CAHN
AB
AB
AB
AB
VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL
VALACYCLOVIR HYDROCHLORIDE
HETERO LABS LTD V
EQ
EQ
SUN PHARM INDS LTD
EQ
EQ
A 203047
A 203047
A 076588
A 076588
001
002
001
002
Mar
Mar
Apr
Apr
A 073484
Jan CAHN
N 022152
N 022152
N 022152
Jan CAHN
Jan CAHN
Jan CAHN
A 204821
A 204821
A 204821
A 204821
001
002
003
004
May
May
May
May
125MG BASE
250MG BASE
A 090439
A 090439
Jan NEWA
Jan NEWA
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL
A 062682
A 062682
A 062682
A 062682
A 062682
001
002
003
004
005
Jun
Jun
Jun
Jun
Jun
500MG BASE/VIAL
1GM BASE/VIAL
A 091377
A 091377
Aug NEWA
Aug NEWA
N 200179
Apr CFTG
A 203689
Apr NEWA
A 090071
A 090071
A 090071
Feb CAHN
Feb CAHN
Feb CAHN
A 202036
A 202036
A 202036
May NEWA
May NEWA
May NEWA
AB
AB
AB
AB
AB
AB
AB
AP
AP
AB
AB
AB
AB
AB
AB
AB
AB
500MG BASE
1GM BASE
500MG BASE
1GM BASE
VALPROIC ACID
CAPSULE;ORAL
VALPROIC ACID
BANNER LIFE SCIENCES 250MG
CAPSULE, DELAYED RELEASE;ORAL
STAVZOR
@ BANNER LIFE SCIENCES 125MG
@
250MG
@
500MG
VALSARTAN
TABLET;ORAL
VALSARTAN
PRINSTON INC
40MG
80MG
160MG
320MG
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOMYCIN HYDROCHLORIDE
LUPIN LTD
EQ
EQ
INJECTABLE;INJECTION
VANCOLED
@ EUROHLTH INTL SARL
EQ
@
EQ
@
EQ
@
EQ
@
EQ
VANCOMYCIN HYDROCHLORIDE
XELLIA PHARMS APS
EQ
EQ
VARDENAFIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
STAXYN
+
BAYER HLTHCARE
10MG
VARDENAFIL HYDROCHLORIDE
WATSON LABS INC
10MG
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VENLAFAXINE HYDROCHLORIDE
VALEANT PHARMS NORTH
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
YAOPHARMA CO LTD
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
Apr
Apr
Jan
Jan
Jun
Jun
Jun
Jun
Jul
Mar
May
May
May
08,
08,
31,
31,
09,
09,
09,
09,
22,
30,
11,
11,
11,
2015
2015
2007
2007
2015
2015
2015
2015
1986
1988
1988
1988
1988
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN
2015
A 202036
A 202036
May NEWA
May NEWA
N 019614
N 019614
N 019614
N 019614
001
003
002
004
Apr
Apr
Apr
Apr
N 020943
N 020943
N 020943
Apr CAHN
Apr CAHN
Apr CAHN
N 018925
Aug CAHN
N 018485
001
Apr CAHN
N 018593
N 018593
N 018593
Apr CAHN
Apr CAHN
Apr CAHN
A 071881
Oct NEWA
15MG/VIAL
N 021119
Mar CAHN
10MG
20MG
40MG
N 022567
N 022567
N 022567
Mar CAHN
Mar CAHN
Mar CAHN
EQ 10MG BASE/ML
A 075992
Sep CAHN
50MG
200MG
A 203503
A 203503
Aug NEWA
Aug NEWA
AB
AB
ZAFIRLUKAST
TABLET;ORAL
ACCOLATE
PAR PHARM INC
+
10MG
20MG
N 020547
N 020547
Feb CAHN
Feb CAHN
AP
AP
AP
AP
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
ZOLEDRONIC ACID
FRESENIUS KABI USA
HOSPIRA INC
MYLAN LABS LTD
USV NORTH AMERICA
EQ
EQ
EQ
EQ
A 091516
A 090621
A 202650
A 202923
001
001
001
001
Apr
Mar
Jul
Mar
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VERELAN
RECRO GAINESVILLE
120MG
180MG
240MG
+
360MG
VERELAN PM
RECRO GAINESVILLE
100MG
200MG
+
300MG
INJECTABLE;INJECTION
CALAN
@ EXELA PHARMA SCS LLC 2.5MG/ML
ISOPTIN
@ MT ADAMS
2.5MG/ML
TABLET;ORAL
ISOPTIN
@ MT ADAMS
40MG
@
80MG
@
120MG
VERAPAMIL HYDROCHLORIDE
HERITAGE PHARMS INC
40MG
VERTEPORFIN
INJECTABLE;INJECTION
VISUDYNE
+
VALEANT LUXEMBOURG
VILAZODONE HYDROCHLORIDE
TABLET;ORAL
VIIBRYD
+
FOREST LABS LLC
AP
AB
AB
VINORELBINE TARTRATE
INJECTABLE;INJECTION
VINORELBINE TARTRATE
EUROHLTH INTL SARL
VORICONAZOLE
TABLET;ORAL
VORICONAZOLE
GLENMARK PHARMS LTD
4MG
4MG
4MG
4MG
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
1 -89
October
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
EQ 75MG BASE
EQ 100MG BASE
10
May
Jan
May
May
Apr
Mar
Mar
Sep
29,
09,
29,
10,
23,
19,
04,
04,
1990
1992
1990
1996
2015
2015
2013
2014
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
CAHN
CPOT
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
2015
A 204232
A 204232
A 203772
A 203772
001
002
001
002
Sep
Sep
Sep
Sep
30,
30,
30,
30,
2015
2015
2015
2015
Sep
Sep
Sep
Sep
NEWA
NEWA
NEWA
NEWA
A 202956
A 202956
A 204336
A 204336
001
002
001
002
Sep
Sep
Oct
Oct
17,
17,
22,
22,
2015
2015
2015
2015
Sep
Sep
Oct
Oct
NEWA
NEWA
NEWA
NEWA
5MG/SPRAY
N 022196
Sep CAHN
5MG
10MG
5MG
10MG
A 078129
A 078129
A 078055
A 078055
001
002
001
002
Mar
Mar
Apr
Apr
1.75MG
3.5MG
N 022328
N 022328
May CFTG
May CFTG
1.75MG
3.5MG
A 204299
A 204299
May NEWA
May NEWA
25MG
50MG
100MG
A 077813
A 077813
A 077813
Jan CAHN
Jan CAHN
Jan CAHN
2.5MG
5MG
MACLEODS PHARMS LTD
2.5MG
5MG
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
JUBILANT GENERICS
2.5MG
5MG
MACLEODS PHARMS LTD
2.5MG
5MG
ZOLPIDEM TARTRATE
SPRAY, METERED;ORAL
ZOLPIMIST
+
AMHERST PHARMS LLC
TABLET;ORAL
ZOLPIDEM TARTRATE
@ HIKMA
@
SUN PHARM INDS LTD
TABLET;SUBLINGUAL
INTERMEZZO
PURDUE PHARMA
+
ZOLPIDEM TARTRATE
NOVEL LABS INC
ZONISAMIDE
CAPSULE;ORAL
ZONISAMIDE
BANNER LIFE SCIENCES
1 -90
October
ZOLMITRIPTAN
TABLET;ORAL
ZOLMITRIPTAN
ALEMBIC PHARMS LTD
10
Apr
Apr
Apr
Apr
30,
30,
23,
23,
2008
2008
2007
2007
DISC
DISC
CAHN
CAHN
35TH
10
EDITION
-
2 -1
October
2015
N 017756
N 017756
002
001
Aug CAHN
Aug CAHN
ACETAMINOPHEN
SUPPOSITORY;RECTAL
TYLENOL
@ J AND J CONSUMER INC
120MG
@
650MG
TABLET, EXTENDED RELEASE;ORAL
ACETAMINOPHEN
SUN PHARM INDS LTD
650MG
@
650MG
TYLENOL
+
J AND J CONSUMER INC
650MG
+
650MG
A 078569
A 090205
Apr CAHN
Apr CAHN
N 019872
N 019872
Aug CAHN
Aug CAHN
N 020045
Mar CAHN
BUDESONIDE
SPRAY, METERED;NASAL
RHINOCORT ALLERGY
+
ASTRAZENECA PHARMS
0.032MG/SPRAY
N 020746
Mar NEWA
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
LOTRIMIN ULTRA
+
BAYER HEALTHCARE LLC
1%
N 021307
Mar CAHN
N 020958
Aug CAHN
N 022429
N 022429
Jan CAHN
Jan CAHN
N 022429
N 022429
Jan CAHN
Jan CAHN
N 022155
Aug CAHN
N 022155
Aug CAHN
A 090760
A 090760
A 077498
A 077498
001
003
001
002
Jul
Jul
Apr
Apr
A 077498
A 077498
Apr CAHN
Apr CAHN
A 090760
A 090760
Jul NEWA
Jul NEWA
N 019835
N 019835
Aug CAHN
Aug CAHN
N 019835
N 019835
Aug CAHN
Aug CAHN
A 091116
A 091116
A 078692
Feb NEWA
Feb NEWA
Feb CTNA
Aug
Aug
Dec
Dec
05,
05,
27,
27,
2015
2015
2007
2007
NEWA
NEWA
CAHN
CAHN
2015
A 078692
Feb CTNA
A 091116
A 091116
Feb NEWA
Feb NEWA
N 021621
N 021621
Aug CAHN
Aug CAHN
N 021621
N 021621
Aug CAHN
Aug CAHN
A 205490
Aug NEWA
N 022578
Aug CAHN
N 021150
Aug CAHN
CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
@ BAYER HEALTHCARE LLC 8MG
+
12MG
N 007638
N 007638
001
002
Mar CAHN
Mar CAHN
N 018397
001
Mar CAHN
CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
@ ANI PHARMS INC
A 073282
Jul CAHN
N 018052
Mar CAHN
N 020574
Mar CAHN
N 020289
Mar CAHN
N 017717
Mar CAHN
A 091070
A 091070
Aug NEWA
Aug NEWA
A 090397
Jan CAHN
10MG
20MG
A 090283
A 090283
Apr CAHN
Apr CAHN
10MG
N 020325
Jul CAHN
1.34MG
CLOTRIMAZOLE
CREAM;VAGINAL
GYNE-LOTRIMIN
+
BAYER HEALTHCARE LLC 1%
GYNE-LOTRIMIN 3
+
BAYER HEALTHCARE LLC 2%
CREAM, TABLET;TOPICAL, VAGINAL
GYNE-LOTRIMIN COMBINATION PACK
+
BAYER HEALTHCARE LLC 1%,100MG
TABLET;VAGINAL
GYNE-LOTRIMIN
+
BAYER HEALTHCARE LLC 100MG
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ACTAVIS LABS FL INC
30MG;600MG
60MG;1.2GM
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
CAPSULE;ORAL
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
BANNER LIFE SCIENCES 25MG;EQ 200MG FREE ACID AND
POTASSIUM SALT
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
SUN PHARM INDS LTD
PEPCID AC
J AND J CONSUMER INC
2 -2
October
TABLET, CHEWABLE;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
+
10MG
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
JUBILANT GENERICS
5MG
10MG
CHILDREN'S ZYRTEC ALLERGY
@ J AND J CONSUMER INC
5MG
@
10MG
CHILDREN'S ZYRTEC HIVES RELIEF
@ J AND J CONSUMER INC
5MG
@
10MG
TABLET, ORALLY DISINTEGRATING;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
PAR PHARM INC
10MG
ZYRTEC ALLERGY
+
J AND J CONSUMER INC 10MG
10
2015
20MG
N 020325
Jul CAHN
10MG
N 020902
Aug CAHN
10MG
20MG
N 020801
N 020801
Aug CAHN
Aug CAHN
A 204507
A 204507
Aug NEWA
Aug NEWA
A 204507
A 204507
Aug NEWA
Aug NEWA
Jan NEWA
GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN
ACTAVIS LABS FL INC
1.2GM
A 091009
Aug NEWA
A 091071
A 091071
May NEWA
May NEWA
IBUPROFEN
CAPSULE;ORAL
IBUPROFEN
BANNER LIFE SCIENCES
A 078682
Jan CAHN
200MG
N 021472
Jan CAHN
100MG/5ML
N 020516
Aug CAHN
40MG/ML
N 020603
Aug CAHN
200MG
200MG
200MG
200MG
A 071144
A 072901
A 072903
A 071144
001
001
001
001
Oct
Aug
Aug
Oct
100MG
N 020602
Aug CAHN
200MG
N 019012
Aug CAHN
200MG
N 019012
Aug CAHN
200MG
200MG
N 019012
N 019012
Aug CAHN
Aug CAHN
50MG
N 020601
Aug CAHN
100MG
N 020601
Aug CAHN
FEXOFENADINE HYDROCHLORIDE
TABLET;ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGY
SCIEGEN PHARMS INC
60MG
180MG
FEXOFENADINE HYDROCHLORIDE HIVES
SCIEGEN PHARMS INC
60MG
180MG
>A>
>D>
2 -3
October
TABLET;ORAL
PEPCID AC
+
PEPCID AC
J AND J CONSUMER INC
TABLET, CHEWABLE;ORAL
PEPCID AC
@ J AND J CONSUMER INC
+
10
Jan
Dec
Dec
Jan
20,
19,
19,
20,
1987
1991
1991
1987
CAHN
CAHN
CAHN
CAHN
2015
A 206581
Jul NEWA
N 021128
Aug CAHN
N 019899
Aug CAHN
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ALAWAY
BAUSCH AND LOMB
EQ 0.035% BASE
N 021996
Feb NEWA
LEVONORGESTREL
TABLET;ORAL
LEVONORGESTREL
LOTUS PHARM CO LTD
OC PHARMA
1.5MG
1.5MG
A 202246
A 202380
May NEWA
May NEWA
1MG
2MG
N 021855
N 021855
Jan CAHN
Jan CAHN
1MG/5ML
N 019487
Aug CAHN
1MG/7.5ML
N 019487
Aug CAHN
2MG
N 019860
Aug CAHN
2MG
N 020448
Aug CAHN
N 021140
Aug CAHN
A 077500
Apr CAHN
N 020606
Aug CAHN
10MG
N 021952
Mar CAHN
1MG/ML
N 020641
Mar CAHN
1MG/ML
N 020641
Mar CAHN
1MG/ML
A 201865
Jul NEWA
10MG
A 076134
Apr CAHN
5MG
N 021891
Mar CAHN
EQ 200MG BASE
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER LIFE SCIENCES
+
SOLUTION;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
SUSPENSION;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
TABLET;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
TABLET, CHEWABLE;ORAL
IMODIUM A-D EZ CHEWS
+
J AND J CONSUMER INC
2 -4
October
IBUPROFEN SODIUM
TABLET;ORAL
IBUPROFEN SODIUM
PERRIGO R AND D
10
2015
N 021993
Mar CAHN
A 077153
Apr CAHN
N 019670
Mar CAHN
N 020470
Mar CAHN
A 076557
Apr CAHN
EQ 200MG BASE
N 021920
Jan CAHN
EQ 200MG BASE
A 091183
Apr CAHN
EQ 2MG BASE
EQ 4MG BASE
A 076880
A 077850
Mar DISC
Mar DISC
A 204152
Jul NEWA
N 022281
Mar CAHN
N 022283
Mar CAHN
N 018471
Mar CAHN
N 022015
Mar CAHN
A 202071
Jan CAHN
A 077442
Apr CAHN
N 020021
Aug CAHN
A 075132
A 078884
Apr CAHN
Jan DISC
OMEPRAZOLE MAGNESIUM
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
PERRIGO R AND D
EQ 20MG BASE
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
ZEGERID OTC
+
BAYER HEALTHCARE LLC 20MG;1.1GM
FOR SUSPENSION;ORAL
ZEGERID OTC
+
BAYER HEALTHCARE LLC 20MG/PACKET;1.68GM/PACKET
OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OCUCLEAR
BAYER HEALTHCARE LLC 0.025%
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
MIRALAX
+
BAYER HEALTHCARE LLC
17GM/SCOOPFUL
POLYETHYLENE GLYCOL 3350
RARITAN PHARMS INC
17GM/SCOOPFUL
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
PSEUDOEPHEDRINE HYDROCHLORIDE
SUN PHARM INDS LTD
120MG
SUDAFED 24 HOUR
+
J AND J CONSUMER INC 240MG
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
@ SUN PHARM INDS LTD
EQ 75MG BASE
@ WOCKHARDT
EQ 75MG BASE
2 -5
October
10
3-1
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
CUMULATIVE SUPPLEMENT NUMBER 10 OCTOBER 2015
4-1
5-1
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY
ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 35TH EDITION
A - 1
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
D-147
D-147
DP U-257
DP
DP
DP
DP U-1263
DP U-1006
DP U-1484
DP U-1078
U-1078
U-1078
U-1078
U-1078
U-1078
DP U-1078
NP
DP
DP
DP
DP
DP
DP
DP
DP
NP
18,
23,
23,
23,
23,
06,
23,
26,
2017
2021
2021
2021
2021
2023
2021
2028
U-1493
A - 2
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-1655
AMBRISENTAN - LETAIRIS
N 022081 001 >A> 8377933
U-1754
>A> I-716
AMBRISENTAN - LETAIRIS
N 022081 002 >A> 8377933
U-1754
>A> I-716
AMOXICILLIN - MOXATAG
N 050813 001
8778924
AMPHETAMINE - DYANAVEL XR
N 208147 001 >A> 8062667
>A> 8597684
>A> 8747902
>A> 8883217
Mar
Mar
Mar
Mar
29,
15,
15,
15,
2029
2027
2027
2027
>A> NP
APIXABAN - ELIQUIS
N 202155 001
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
03,
03,
03,
03,
03,
03,
03,
03,
03,
2023
2023
2023
2023
2023
2023
2023
2023
2023
DS
DS
DS
DS
DS
DS
DS
DS
DS
DP
DP
DP
DP
DP
DP
DP
DP
DP
U-1167
U-1200
U-1301
U-1302
U-1323
U-1501
U-1502
U-1729
U-1730
APIXABAN - ELIQUIS
N 202155 002
6413980
6413980
6413980
6967208
6967208
6967208
6967208
Dec
Dec
Dec
Feb
Feb
Feb
Feb
22,
22,
22,
03,
03,
03,
03,
2019
2019
2019
2023
2023
2023
2023
DS
DS
DS
DS
DS
DS
DS
DP
DP
DP
DP
DP
DP
DP
U-1200
U-1301
U-1302
U-1200
U-1301
U-1302
U-1323
APREMILAST - OTEZLA
N 205437 001
9018243
9018243
U-1505
U-1595
APREMILAST - OTEZLA
N 205437 002
9018243
9018243
U-1505
U-1595
APREMILAST - OTEZLA
N 205437 003
9018243
9018243
U-1505
U-1595
DS DP U-897
DP
DP
DP
DP
A - 3
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
APREPITANT - EMEND
N 021549 001
6096742
6096742
6096742
8258132
8258132
Jul
Jul
Jul
Sep
Sep
01,
01,
01,
26,
26,
2018
2018
2018
2027
2027
DS DP U-745
DS DP U-1743
DS DP U-1744
DP U-901
DP U-1743
NPP
APREPITANT - EMEND
N 021549 002
6096742
6096742
6096742
8258132
8258132
Jul
Jul
Jul
Sep
Sep
01,
01,
01,
26,
26,
2018
2018
2018
2027
2027
DS DP U-745
DS DP U-1743
DS DP U-1744
DP U-901
DP U-1743
NPP
APREPITANT - EMEND
N 021549 003
6096742
6096742
6096742
8258132
8258132
Jul
Jul
Jul
Sep
Sep
01,
01,
01,
26,
26,
2018
2018
2018
2027
2027
DS DP U-745
DS DP U-1743
DS DP U-1744
DP U-901
DP U-1743
NPP
ARIPIPRAZOLE - ABILIFY
N 021436 001
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021436 002
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021436 003
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021436 004
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021436 005
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021436 006
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021713 001
5006528
5006528
5006528*PED
6977257
6977257*PED
Oct
Oct
Apr
Apr
Oct
ODE
ARIPIPRAZOLE - ABILIFY
N 021729 002
9089567
9125939
U-543
U-1749
ODE
ARIPIPRAZOLE - ABILIFY
N 021729 003
9089567
9125939
U-543
U-1749
ODE
20,
20,
20,
24,
24,
2014
2014
2015
2022
2022
DS DP U-543
DS DP U-761
DP
A - 4
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
ARIPIPRAZOLE - ABILIFY
N 021729 004
ODE
ARIPIPRAZOLE - ABILIFY
N 021729 005
ODE
ODE
ARIPIPRAZOLE - ABILIFY
N 021866 001
5006528
5006528
5006528*PED
8030313
Oct 19, 2024
8030313
Oct 19, 2024
DS DP U-543
DS DP U-763
DS DP U-543
DS DP U-1632
DP
DP
DP
DP
U-543
U-1632
U-543
U-1633
U-543
U-1633
DS
DP U-1530
DP U-1633
DS
U-543
DS DP U-543
DS DP U-1632
DP
DP
DP
DP
U-543
U-1632
U-543
U-1633
U-543
U-1633
DS
DP U-1530
DP U-1633
DS
U-543
DS DP U-543
DS DP U-1632
DP
DP
DP
DP
U-543
U-1632
U-543
U-1633
U-543
U-1633
DS
DP U-1530
DP U-1633
DS
U-543
DS DP U-543
DS DP U-1632
U-543
U-1632
A - 5
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DP
DP
DP
DP
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-543
U-1633
U-543
U-1633
DS
DP U-1530
DP U-1633
DS
U-543
DS
DS
DS
Jun
Dec
Apr
Oct
Apr
Oct
09,
09,
06,
06,
06,
06,
2020
2020
2026
2026
2026
2026
Jun
Dec
Apr
Oct
Apr
Oct
09,
09,
06,
06,
06,
06,
2020
2020
2026
2026
2026
2026
ASPIRIN - ASPIRIN
N 203697 001
9101637
9101637
9101637
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
>A> NCE
>A> NCE
>A> NCE
U-543
DP U-543
U-543
DP U-543
U-543
DP U-543
DP U-326
DS DP U-1064
M-158
NPP
PED
PED
Mar
Mar
Sep
Sep
17,
17,
17,
17,
2018
2018
2018
2018
M-158
NPP
PED
PED
Mar
Mar
Sep
Sep
17,
17,
17,
17,
2018
2018
2018
2018
DS DP
DP U-326
DS DP U-1064
DS DP
U-1731
U-1732
U-1733
DS DP
DS DP
DS DP
A - 6
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
Jun
Dec
Dec
Jun
20,
20,
21,
21,
2017
2017
2018
2019
DS DP U-167
24,
12,
24,
12,
08,
15,
2022
2026
2021
2031
2030
2032
08,
18,
01,
24,
24,
2019
2027
2024
2023
2023
Sep
Sep
Mar
Oct
Oct
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DS DP
DS DP
DS DP
NP
NPP
PED
PED
Jun
Sep
Dec
Mar
02,
24,
02,
24,
2017
2018
2017
2019
NP
NPP
NPP
NPP
DS DP U-167
DS DP
DS DP U-1279
DS DP U-282
DP
DS DP U-282
DS
DP
DS
DP
DP
U-1727
DP
DP
DP
DP
DP
DP
A - 7
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-124
DP
U-80
DP U-1761
DP U-1761
>A> NP
BEXAROTENE - TARGRETIN
N 021055 001
BIMATOPROST - LUMIGAN
N 022184 001
8933120
8933127
BIMATOPROST - LATISSE
N 022369 001
7351404
7388029
8541466
8986715
May
Jan
Jan
Jan
25,
21,
31,
15,
2024
2022
2021
2023
BORTEZOMIB - VELCADE
N 021602 001
5780454
5780454*PED
6713446
6713446*PED
6958319
6958319*PED
May
Nov
Jan
Jul
Jan
Jul
03,
03,
25,
25,
25,
25,
2017
2017
2022
2022
2022
2022
BREXPIPRAZOLE - REXULTI
N 205422 001
7888362
8349840
8618109
DS
BREXPIPRAZOLE - REXULTI
N 205422 002
7888362
8349840
8618109
DS
BREXPIPRAZOLE - REXULTI
N 205422 003
7888362
8349840
8618109
DS
BREXPIPRAZOLE - REXULTI
N 205422 004
7888362
8349840
8618109
DS
BREXPIPRAZOLE - REXULTI
N 205422 005
7888362
8349840
8618109
DS
M-164
D-141
D-142
I-695
M-139
M-165
ODE
PED
PED
PED
PED
PED
PED
Oct
Oct
Oct
Aug
Sep
Oct
Feb
Apr
Apr
Apr
Mar
Apr
NCE
NCE
NCE
NCE
NCE
DP
DP
U-939
U-938
U-1217
U-1217
DS DP
DS DP
DS DP
Y
Y
08,
08,
08,
08,
14,
08,
08,
08,
08,
08,
14,
08,
2017
2017
2017
2017
2018
2021
2018
2018
2018
2018
2019
2022
DP U-1529
U-543
DP U-1529
U-543
DP U-1529
U-543
DP U-1529
U-543
DP U-1529
U-543
A - 8
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT
EXPIRATION
DATE
PATENT NO
BREXPIPRAZOLE - REXULTI
N 205422 006
7888362
8349840
8618109
PATENT
CODES
DS
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
NCE
EXCLUSIVITY
EXPIRATION
DATE
DP U-1529
U-543
DP
DP
DP U-1706
BUDESONIDE - UCERIS
N 203634 001
9132093
DP
BUDESONIDE - UCERIS
N 205613 001
5914122
DP
>A> NP
>A> NP
>A> NP
>A> NP
>A> NP
>A> NP
>A> NP
I-713
I-713
I-713
I-713
I-713
A - 9
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
HYDROCHLORIDE - CONTRAVE
Feb 02, 2030
U-1639
Jun 04, 2027
U-1639
Nov 08, 2027
U-1585
DP
U-1469
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
N 207026 001
ODE
Jan 13, 2022
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
N 207026 002
ODE
Jan 13, 2022
CANGRELOR - KENGREAL
N 204958 001
6114313
6130208
8680052
8759316
Dec
Jun
Mar
May
11,
29,
09,
13,
2017
2018
2033
2029
DP U-1715
DP U-1715
U-1715
U-1715
NCE
May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
DP U-1645
DP U-219
DP U-1645
DP U-219
DP U-1645
DP U-1646
DP U-1647
DP U-1649
DP U-219
DP U-1645
DP U-1645
DP U-1720
DP
NDF
May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
DP U-1645
DP U-219
DP U-1645
DP U-219
DP U-1645
DP U-1646
DP U-1647
DP U-1649
DP U-219
DP U-1645
DP U-1645
DP U-1720
DP
NDF
May
Dec
Dec
Dec
Dec
29,
26,
26,
26,
26,
2022
2028
2028
2028
2028
DP
DP
DP
DP
DP
NDF
U-1645
U-219
U-1645
U-219
U-1645
A - 10
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
26,
26,
26,
26,
26,
26,
26,
26,
2028
2028
2028
2028
2028
2028
2028
2028
DP U-1646
DP U-1647
DP U-1649
DP U-219
DP U-1645
DP U-1645
DP U-1720
DP
May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
DP U-1645
DP U-219
DP U-1645
DP U-219
DP U-1645
DP U-1646
DP U-1647
DP U-1649
DP U-219
DP U-1645
DP U-1645
DP U-1720
DP
CARFILZOMIB - KYPROLIS
N 202714 001
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
NDF
NP
ODE
I-712
DS DP U-1750
DS DP
NCE
DS DP U-1750
DS DP
NCE
DS DP U-1750
DS DP
NCE
DS DP U-1750
DS DP
NCE
DS DP U-1676
DS DP U-1676
PC
U-1672
U-1673
A - 11
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
CELECOXIB - CELECOXIB
A 076898 003
PC
CELECOXIB - CELECOXIB
A 076898 004
PC
CELECOXIB - CELECOXIB
A 078857 002
PC
CELECOXIB - CELECOXIB
A 078857 003
PC
CELECOXIB - CELECOXIB
A 078857 004
PC
CELECOXIB - CELECOXIB
A 200562 002
PC
CELECOXIB - CELECOXIB
A 200562 003
PC
CELECOXIB - CELECOXIB
A 200562 004
PC
ODE
ODE
PC
CICLESONIDE - ALVESCO
N 021658 002
8371292
U-1355
CICLESONIDE - ALVESCO
N 021658 003
8371292
U-1355
CICLESONIDE - OMNARIS
N 022004 001
8371292
U-1356
CICLESONIDE - ZETONNA
N 202129 001
8371292
U-1357
DP U-1578
A - 12
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
8597876
Jun 23, 2019
8597876*PED
Dec 23, 2019
RE42889
Oct 19, 2016
RE42889*PED
Apr 19, 2017
RE43596
May 09, 2017
RE43596*PED
Nov 09, 2017
RE43802
Oct 19, 2016
RE43802*PED
Apr 19, 2017
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-1410
DP U-1660
U-1660
DS DP
DS DP U-1660
DS DP
U-1660
DP
DS DP
U-1660
I-704
COLCHICINE - MITIGARE
N 204820 001
8927607
CRIZOTINIB - XALKORI
N 202570 001
7230098
DS
M-163
CRIZOTINIB - XALKORI
N 202570 002
7230098
DS
M-163
CROFELEMER - FULYZAQ
N 202292 001
8962680
CYANOCOBALAMIN - NASCOBAL
N 021642 001
7229636
7879349
8003353
8940714
Aug
Aug
Aug
Feb
DP
NPP
DP
NPP
01,
01,
01,
26,
2024
2024
2024
2024
U-1020
U-1319
DP U-817
DP U-1152
U-817
U-1152
U-1759
U-1759
DS DP U-1713
DS DP U-1713
A - 13
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DS
DS DP U-1724
DS DP U-1724
DS DP U-1725
U-1724
U-1725
NCE
DS
DS DP U-1724
DS DP U-1724
DS DP U-1725
U-1724
U-1725
NCE
ODE
M-157
M-157
DEFERASIROX - EXJADE
N 021882 001
ODE
DEFERASIROX - EXJADE
N 021882 002
ODE
DEFERASIROX - EXJADE
N 021882 003
ODE
N 206619 001
6037157
Jun 26, 2016
U-1635
6703403
Jun 26, 2016
U-1635
7148359
Jul 19, 2019
DP
7364752
Nov 10, 2020
DP
8188104
May 17, 2029
DS DP U-1636
8268349
Aug 25, 2024
DP
8399015
Aug 25, 2024
DP
8420596
Apr 10, 2031
DS DP
8466159
Sep 04, 2032
U-1637
8492386
Sep 04, 2032
U-1637
8501238
Sep 17, 2028
DS DP U-1636
8642538
Sep 10, 2029
DS DP U-1638
8680106
Sep 04, 2032
U-1637
8685984
Sep 04, 2032
U-1637
8686026
Jun 09, 2031
DP
8691938
Apr 13, 2032
DS DP
9006387
Jun 10, 2030
U-1687
9044480
Apr 10, 2031
U-1638
>A> 9139536
Nov 09, 2028
U-1753
DEFERASIROX - JADENU
N 206910 001
6465504
6596750
DS DP
DS
U-735
DEFERASIROX - JADENU
N 206910 002
6465504
6596750
DS DP
DS
U-735
A - 14
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DEFERASIROX - JADENU
N 206910 003
6465504
6596750
DS DP
DS
U-735
DEFERIPRONE - FERRIPROX
N 021825 001
7049328
U-735
DEFERIPRONE - FERRIPROX
N 208030 001
7049328
8703156
U-735
DP U-735
Dec
Dec
Mar
May
Aug
Mar
Feb
Feb
Mar
Feb
Feb
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
NCE
ODE
PC
PC
10,
10,
02,
16,
03,
02,
21,
21,
02,
08,
21,
2027
2027
2030
2028
2025
2030
2028
2028
2030
2025
2028
DESONIDE - VERDESO
N 021978 001
8962000
DEXAMETHASONE - OZURDEX
N 022315 001
8043628
8088407
9012437
DEXLANSOPRAZOLE - DEXILANT
N 022287 001
9011926
>A> 9145389
DEXLANSOPRAZOLE - DEXILANT
N 022287 002
8784885
8784885
8784885
8784885*PED
9011926
>A> 9145389
Oct
Oct
Oct
Apr
Feb
Jun
15,
15,
15,
15,
24,
15,
2023
2023
2023
2024
2026
2020
U-1690
U-1690
DP
DS
U-1690
DP
DP
DP U-1690
DP
U-1690
DP
DP U-1412
DS
DS
DS
U-860
U-1364
U-1205
U-1205
U-1205
DP
DS DP
DP U-1552
DP U-1553
DP U-1554
DP
DS DP
U-1472
DP
DP
U-421
A - 15
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP
PC
PC
DICHLORPHENAMIDE - KEVEYIS
N 011366 002
ODE
M-166
DICLOFENAC - ZORVOLEX
N 204592 001
8999387
9017721
>A> 9173854
>A> 9180096
Apr
Apr
Apr
Apr
23,
23,
23,
23,
2030
2030
2030
2030
DP
DP
DP
DICLOFENAC - ZORVOLEX
N 204592 002
8999387
9017721
>A> 9173854
>A> 9180096
Apr
Apr
Apr
Apr
23,
23,
23,
23,
2030
2030
2030
2030
DP
DP
DP
DP
Oct
Oct
Oct
Oct
Oct
DP U-1488
DP U-1488
U-1488
DP
U-1488
17,
17,
17,
16,
17,
2027
2027
2027
2027
2027
U-55
U-55
U-436
U-1659
DP
A - 16
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-620
DP U-620
DP U-918
DP
U-1726
U-1728
PC
DS
NCE
DS
NCE
DS
NCE
D-149
I-711
ODE
PED
PED
PED
Jun
Jun
Aug
Dec
Dec
Feb
Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
11,
11,
26,
11,
11,
26,
2018
2018
2021
2018
2018
2022
A - 17
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
2021
2021
2021
2021
2021
2021
2021
2021
2025
2025
2025
2025
2026
2021
2021
2021
2021
2021
2023
2023
2023
2023
2023
2027
2027
2027
2027
2028
2027
2028
2027
2028
2027
2028
2027
2027
2027
2028
Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2025
2025
2025
2025
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DS DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DP U-1714
DP U-1714
DP U-1714
DP U-1306
DP U-1619
DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DS DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
D-149
I-711
ODE
PED
PED
PED
Jun
Jun
Aug
Dec
Dec
Feb
11,
11,
26,
11,
11,
26,
2018
2018
2021
2018
2018
2022
A - 18
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
2026
2021
2021
2021
2021
2021
2023
2023
2023
2023
2023
2027
2028
2027
2027
2027
2027
2028
2027
2028
2027
2028
2027
2027
2027
2028
Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2025
2025
2025
2025
2026
2021
2021
2021
2021
2021
2023
2023
2023
2023
2023
2027
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DP U-1714
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DP U-1714
DP U-1714
DP U-1306
DP U-1619
DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DS DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DP U-1714
D-149
I-711
ODE
PED
PED
PED
Jun
Jun
Aug
Dec
Dec
Feb
11,
11,
26,
11,
11,
26,
2018
2018
2021
2018
2018
2022
A - 19
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
2028
2027
2028
2027
2027
2027
2027
2028
2027
2028
2027
2027
2027
2028
Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Aug
30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2025
2025
2025
2025
2026
2021
2021
2021
2021
2021
2023
2023
2023
2023
2023
2027
2028
2027
2028
2027
2028
2027
2027
2027
2027
2028
2027
2027
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-1714
DP
DP
DP
DP
U-714
U-930
U-1306
U-1575
DP U-1714
DP U-1306
DP U-1619
DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DS DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714
DP U-1714
DP U-1714
DP U-1714
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DP U-1306
DP U-1619
D-149
I-711
ODE
PED
PED
PED
Jun
Jun
Aug
Dec
Dec
Feb
11,
11,
26,
11,
11,
26,
2018
2018
2021
2018
2018
2022
A - 20
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jan
May
May
May
Nov
May
May
May
Nov
Aug
Aug
Feb
30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
24,
24,
24,
24,
21,
21,
21,
21,
01,
01,
01,
2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2025
2025
2025
2026
2021
2021
2021
2021
2023
2023
2023
2023
2027
2027
2028
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
Oct
Nov
May
May
May
Jul
May
May
30,
20,
24,
24,
24,
13,
24,
24,
2018
2022
2021
2021
2021
2025
2021
2023
ELUXADOLINE - VIBERZI
N 206940 001
7741356
7786158
8344011
8609709
8691860
9115091
Mar
Mar
Mar
Mar
Jul
Jul
25,
14,
14,
14,
07,
07,
ELUXADOLINE - VIBERZI
N 206940 002
7741356
7786158
8344011
8609709
Mar
Mar
Mar
Mar
25,
14,
14,
14,
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-1714
D-149
I-711
ODE
PED
PED
PED
Jun
Jun
Aug
Dec
Dec
Feb
11,
11,
26,
11,
11,
26,
2018
2018
2021
2018
2018
2022
DS DP U-1736
DS DP U-1736
U-1736
DS DP
DS DP U-1736
DS DP U-1736
U-1736
U-1736
D-149
I-711
ODE
PED
PED
Jun
Jun
Nov
Dec
Dec
11,
11,
20,
11,
11,
2018
2018
2015
2018
2018
2028
2025
2025
2025
2028
2028
DS DP
DS
NCE
2028
2025
2025
2025
DS DP
DS
NCE
U-930
U-1306
U-1575
U-1714
DS DP U-1714
DS
DS
DS
DS
DP
DP
DP
DP
U-930
U-1306
U-1575
U-1714
DS DP U-930
DS DP U-1306
DS DP U-1575
U-930
U-1306
U-1575
U-930
U-1306
U-1575
DP U-1306
DP U-1575
U-1709
DS
DS
U-1709
DS DP U-1738
U-1709
DS
A - 21
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
ELUXADOLINE - VIBERZI
N 206940 002
8691860
9115091
DS
U-1709
DS DP U-1738
ELVITEGRAVIR - VITEKTA
N 203093 001
8981103
DS DP
ELVITEGRAVIR - VITEKTA
N 203093 002
8981103
DS DP
EMPAGLIFLOZIN - JARDIANCE
N 204629 001
EMPAGLIFLOZIN - JARDIANCE
N 204629 002
24,
02,
02,
12,
02,
05,
15,
12,
12,
12,
19,
04,
04,
26,
2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2027
2030
2025
24,
02,
02,
12,
02,
05,
15,
12,
12,
12,
19,
04,
04,
26,
2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2024
2030
2025
U-1651
U-1652
U-1651
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
M-160
M-161
M-160
M-161
NC
NCE
NCE
NC
NCE
NCE
DS DP
U-1651
DS
DS DP
DP
DP
DP
DP
U-1651
U-1653
U-1654
U-1651
U-1652
U-1652
DP
U-1651
U-1652
U-1651
DS DP
U-1651
DS
DS DP
DP
DP
DP
DP
U-1651
U-1653
U-1654
U-1651
U-1652
U-1652
DP
DS
DS DP
NCE
NP
DS
DS DP
NCE
NP
DS
DS DP
NCE
NP
A - 22
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
DS
DS DP
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
NCE
NP
I-671
PED
I-671
PED
I-671
PED
EPINEPHRINE - AUVI-Q
N 201739 001
8920377
8926594
9056170
>A> 9149579
Nov
Mar
Nov
Jul
23,
31,
23,
19,
2024
2026
2024
2025
DP
DP
DP
EPINEPHRINE - AUVI-Q
N 201739 002
8920377
8926594
9056170
>A> 9149579
Nov
Mar
Nov
Jul
23,
31,
23,
19,
2024
2026
2024
2025
DP
DP
DP
EPINEPHRINE - ADRENALIN
N 204640 001
9119876
DP
DS
Nov
May
Nov
Nov
Nov
Nov
May
Nov
Nov
Nov
May
Nov
May
08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,
2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019
DS DP U-659
Nov
May
Nov
Nov
Nov
Nov
May
Nov
Nov
Nov
May
Nov
May
08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,
2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019
DS DP U-659
Nov
May
Nov
Nov
Nov
08,
08,
09,
09,
09,
2018
2019
2020
2020
2020
DS DP U-659
U-1588
U-1758
U-1758
DS
DS
DS
DS
DP
DP
DP
DP
U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403
DS DP
DS
DS
DS
DS
DP
DP
DP
DP
U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403
DS DP
DS DP U-659
DS DP U-875
DS DP U-1046
A - 23
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
Nov
May
Nov
Nov
Nov
May
Nov
May
DS DP U-1451
DS DP U-1746
D-150
I-715
DS DP U-1451
DS DP U-1746
D-150
I-715
DS DP U-1451
DS DP U-1746
D-150
I-715
DS DP U-1451
DS DP U-1746
D-150
I-715
09,
09,
09,
09,
09,
09,
08,
08,
25,
25,
03,
03,
27,
04,
04,
25,
25,
03,
03,
27,
25,
25,
2020
2021
2020
2020
2020
2021
2018
2019
2014
2015
2015
2015
2014
2016
2016
2018
2018
2019
2020
2014
2018
2018
DS DP U-1403
U-659
U-1045
U-1403
DS DP
DP U-1509
DP U-1509
DS
U-1509
DS DP U-1509
DP U-1509
DS
U-1661
U-1760
U-1661
U-1760
ESTRADIOL - MINIVELLE
N 203752 005
6841716
8231906
DP
DS DP
EVEROLIMUS - AFINITOR
N 022334 001
8410131
8410131*PED
9006224
DS DP U-1368
EVEROLIMUS - AFINITOR
N 022334 002
8410131
8410131*PED
9006224
DS DP U-1368
U-1681
U-1681
A - 24
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
EVEROLIMUS - AFINITOR
N 022334 002
8410131
8410131*PED
9006224
DS DP U-1368
EVEROLIMUS - AFINITOR
N 022334 003
8410131
8410131*PED
9006224
DS DP U-1368
EVEROLIMUS - AFINITOR
N 022334 004
8410131
8410131*PED
9006224
DS DP U-1368
EXCLUSIVITY
CODE(S)
U-1681
U-1681
M-162
FEBUXOSTAT - ULORIC
N 021856 001
9107912
U-1346
FEBUXOSTAT - ULORIC
N 021856 002
9107912
U-1346
DP
DP
Jan
Nov
Sep
May
Jun
Mar
Jan
DP U-736
DP
DP
U-736
DP U-736
DP U-736
DP
U-1577
U-1577
U-1656
U-1656
DP U-1656
02,
02,
30,
21,
11,
31,
17,
2018
2019
2031
2032
2032
2032
2033
Apr
Apr
Aug
Jul
12,
12,
08,
02,
2017
2017
2031
2030
EXCLUSIVITY
EXPIRATION
DATE
U-1681
FINAFLOXACIN - XTORO
N 206307 001
6133260
6432948
8536167
9119859
PATENT
DELIST
REQUESTED
DP
DS DP
DS DP
U-1679
U-1679
A - 25
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
FLIBANSERIN - ADDYI
N 022526 001
7151103
7420057
8227471
FLUOROURACIL - TOLAK
N 022259 001 >A> 7169401
DP
DP
DP
U-1734
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
NCE
NP
I-708
NP
NPP
M-155
M-155
NP
ODE
DS DP
U-1734
GEFITINIB - IRESSA
N 206995 001 >A> 5770599
DS DP U-1755
U-441
U-441
U-1383
A - 26
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
PC
PC
PC
PC
M-154
M-154
M-154
M-154
DP
DP
DP
DP
DP
DP
Oct
Oct
Oct
Aug
Aug
Aug
30,
30,
30,
24,
24,
24,
2021
2021
2021
2027
2027
2027
DP
DP
Oct
Oct
Oct
Aug
Aug
Aug
30,
30,
30,
24,
24,
24,
2021
2021
2021
2027
2027
2027
DP
DP
DP
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
A - 27
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
Oct
Aug
Aug
Aug
30,
24,
24,
24,
2021
2027
2027
2027
Oct
Oct
Oct
Aug
Aug
Aug
30,
30,
30,
24,
24,
24,
2021
2021
2021
2027
2027
2027
DP
DP
Oct
Oct
Aug
Aug
Aug
30,
30,
24,
24,
24,
2021
2021
2027
2027
2027
DP
Oct
Oct
Aug
Aug
Aug
30,
30,
24,
24,
24,
2021
2021
2027
2027
2027
DP
Oct
Oct
Aug
Aug
Aug
30,
30,
24,
24,
24,
2021
2021
2027
2027
2027
DP
IBRUTINIB - IMBRUVICA
N 205552 001
8497277
8497277
8497277
8957079
8999999
8999999
9125889
Dec
Dec
Dec
Dec
Jun
Jun
Jun
28,
28,
28,
28,
03,
03,
03,
2026
2026
2026
2026
2031
2031
2031
IBUPROFEN - CALDOLOR
N 022348 002
8871810
9012508
9114068
>A> 9138404
Sep
Sep
Sep
Sep
30,
14,
30,
30,
2029
2030
2029
2029
U-1599
U-981
U-1735
U-1756
DS DP U-1187
IDELALISIB - ZYDELIG
N 205858 001
8138195
8865730
8980901
>A> 9149477
RE44599
RE44599
Apr
Mar
May
May
Jul
Jul
2021
2033
2025
2025
2025
2025
DS DP U-1549
DS DP U-1615
U-1678
U-1757
U-1558
U-1615
IDELALISIB - ZYDELIG
N 205858 002
8138195
8865730
DS DP U-1549
DS DP U-1615
24,
05,
12,
12,
21,
21,
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1556
DP
U-1456
U-1491
U-1650
DS DP
U-1683
U-1684
U-1745
I-702
ODE
A - 28
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
IDELALISIB - ZYDELIG
N 205858 002
8980901
>A> 9149477
RE44599
RE44599
May
May
Jul
Jul
12,
12,
21,
21,
2025
2025
2025
2025
U-1678
U-1757
U-1558
U-1615
ILOPERIDONE - FANAPT
N 022192 001
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 002
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 003
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 004
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 005
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 006
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
A - 29
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
ILOPERIDONE - FANAPT
N 022192 006
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
ILOPERIDONE - FANAPT
N 022192 007
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
31,
28,
16,
28,
17,
10,
30,
05,
2030
2030
2031
2031
2030
2031
2025
2030
U-1685
U-1674
U-1674
U-1674
U-1674
U-1674
U-1737
U-1674
DS DP U-1168
INDOMETHACIN - TIVORBEX
N 204768 001
8992982
9089471
DP
INDOMETHACIN - TIVORBEX
N 204768 002
8992982
9089471
DP
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-55
U-55
DP
DP
DP
N 203313 001
5866538
Jun 20, 2017
6899699
Jan 02, 2022
7615532
May 25, 2025
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032
DP
DP
DS DP
DP
DP
DP
DP
DP
DP
NCE
Jan
May
Aug
Jan
Oct
Jul
Jan
Feb
02,
25,
03,
02,
20,
17,
20,
01,
2022
2025
2026
2022
2025
2026
2026
2032
DP
DS DP
DP
DP
DP
DP
DP
DP
NCE
Jan
May
Aug
Jan
Oct
Jul
02,
25,
03,
02,
20,
17,
2022
2025
2026
2022
2025
2026
DP
DS DP
DP
DP
DP
DP
NCE
A - 30
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP U-1707
DP U-1708
DP U-1707
DP U-1708
DP
DP
DP U-1538
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
NP
NP
DP
DP
DP
DP
DP
DP
PATENT
DELIST
REQUESTED
U-1539
DP
U-1537
DP
DP U-1538
DP U-1534
U-1535
DP
DP
U-1535
DP U-1535
U-1539
U-1537
DP
DP
DP
U-1537
DP U-1697
DP U-1533
DP
DP
DP
DP
A - 31
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
U-1537
DP
DP
DP
DP U-1538
DP U-1621
DP U-1538
DP
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
>A> NP
EXCLUSIVITY
EXPIRATION
DATE
DS
DS
NCE
ODE
GAIN
GAIN
Mar
Mar
Mar
Mar
06,
06,
06,
06,
2020
2022
2025
2027
DS
DS
NCE
ODE
GAIN
GAIN
Mar
Mar
Mar
Mar
06,
06,
06,
06,
2020
2022
2025
2027
ISOTRETINOIN - ABSORICA
N 021951 001
8952064
9078925
9089534
DP
DP
DP
ISOTRETINOIN - ABSORICA
N 021951 002
8952064
9078925
9089534
DP
DP
DP
ISOTRETINOIN - ABSORICA
N 021951 003
8952064
9078925
9089534
DP
DP
DP
ISOTRETINOIN - ABSORICA
N 021951 004
8952064
9078925
9089534
DP
DP
DP
ISOTRETINOIN - ABSORICA
N 021951 005
7435427
8367102
8952064
9078925
9089534
Sep
Sep
Sep
Sep
Sep
21,
21,
21,
21,
21,
2021
2021
2021
2021
2021
DP
ISOTRETINOIN - ABSORICA
N 021951 006
7435427
8367102
8952064
9078925
9089534
Sep
Sep
Sep
Sep
Sep
21,
21,
21,
21,
21,
2021
2021
2021
2021
2021
DP
U-1347
DP
DP
DP
U-1347
DP
DP
DP
A - 32
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
17,
14,
22,
22,
2026
2026
2026
2026
DS
DS
DS
DS
DP
DP
DP
DP
U-1694
U-1694
U-1694
U-1694
NCE
17,
14,
22,
22,
2026
2026
2026
2026
DS
DS
DS
DS
DP
DP
DP
DP
U-1694
U-1694
U-1694
U-1694
NCE
U-1311
I-705
NCE
ODE
IVACAFTOR - KALYDECO
N 203188 001
8354427
IVACAFTOR - KALYDECO
N 207925 001
7495103
8324242
8354427
8410274
8754224
8883206
May
Apr
Jul
Dec
Dec
Feb
20,
18,
06,
28,
28,
27,
2027
2027
2026
2026
2026
2033
DS DP
IVACAFTOR - KALYDECO
N 207925 002
7495103
8324242
8354427
8410274
8754224
8883206
May
Apr
Jul
Dec
Dec
Feb
20,
18,
06,
28,
28,
27,
2027
2027
2026
2026
2026
2033
DS DP
May
Apr
Dec
Sep
Dec
Nov
Nov
Dec
Dec
Dec
20,
18,
28,
20,
04,
08,
08,
28,
04,
11,
2027
2027
2026
2030
2028
2026
2026
2026
2028
2030
DS DP
IVERMECTIN - SOOLANTRA
N 206255 001
5952372
6133310
7550440
8080530
8093219
8415311
8470788
8815816
9089587
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Mar
18,
26,
22,
22,
22,
22,
22,
22,
13,
2018
2019
2024
2024
2024
2024
2024
2024
2034
U-1311
U-1311
DP
DS DP
DP
U-1311
U-1311
DP
DS DP
DP
U-1311
DP
DS DP
DP
DP U-1718
U-1717
DS DP
U-1717
DP
DP
DP
DP
DP
DP
DP
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1662
DP
A - 33
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
LAMIVUDINE - LAMIVUDINE
A 203564 001
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
PC
LAMIVUDINE - EPIVIR
N 020564 001
5905082
5905082*PED
DS DP
D-147
LAMIVUDINE - EPIVIR
N 020564 003
5905082
5905082*PED
DS DP
D-147
LAMIVUDINE - EPIVIR
N 020596 001
5905082
6004968
6004968*PED
DS DP
DP U-248
D-147
LAMOTRIGINE - LAMOTRIGINE
A 200828 001
PC
LAMOTRIGINE - LAMOTRIGINE
A 200828 002
PC
LAMOTRIGINE - LAMOTRIGINE
A 200828 003
PC
LAMOTRIGINE - LAMOTRIGINE
A 200828 004
PC
LAMOTRIGINE - LAMICTAL
N 020241 001
M-159
LAMOTRIGINE - LAMICTAL
N 020241 002
M-159
LAMOTRIGINE - LAMICTAL
N 020241 003
M-159
LAMOTRIGINE - LAMICTAL
N 020241 004
M-159
LAMOTRIGINE - LAMICTAL
N 020241 005
M-159
LAMOTRIGINE - LAMICTAL
N 020241 006
M-159
LAMOTRIGINE - LAMICTAL CD
N 020764 001
M-159
LAMOTRIGINE - LAMICTAL CD
N 020764 002
M-159
DS DP
U-1663
U-1663
DS DP U-1663
DS
A - 34
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
LAMOTRIGINE - LAMICTAL CD
N 020764 003
M-159
LAMOTRIGINE - LAMICTAL CD
N 020764 004
M-159
M-159
M-159
M-159
M-159
LAMOTRIGINE - LAMICTAL XR
N 022115 001 >A> 9144547
DP
LAMOTRIGINE - LAMICTAL XR
N 022115 002 >A> 9144547
DP
LAMOTRIGINE - LAMICTAL XR
N 022115 003 >A> 9144547
DP
LAMOTRIGINE - LAMICTAL XR
N 022115 004 >A> 9144547
DP
LAMOTRIGINE - LAMICTAL XR
N 022115 005 >A> 9144547
DP
LAMOTRIGINE - LAMICTAL XR
N 022115 006 >A> 9144547
DP
DP
DP
DS DP
DS DP U-1470
LENALIDOMIDE - REVLIMID
N 021880 001
9056120
9101621
9101622
U-1215
U-1216
U-1216
I-706
ODE
LENALIDOMIDE - REVLIMID
N 021880 002
9056120
9101621
9101622
U-1215
U-1216
U-1216
I-706
ODE
A - 35
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
LENALIDOMIDE - REVLIMID
N 021880 003
9056120
9101621
9101622
U-1215
U-1216
U-1216
I-706
ODE
LENALIDOMIDE - REVLIMID
N 021880 004
9056120
9101621
9101622
U-1215
U-1216
U-1216
I-706
ODE
LENALIDOMIDE - REVLIMID
N 021880 005
9056120
9101621
9101622
U-1215
U-1216
U-1216
I-706
ODE
LENALIDOMIDE - REVLIMID
N 021880 006
5635517
9056120
9101621
9101622
Oct
Apr
May
May
U-1211
U-1215
U-1216
U-1216
I-706
ODE
DS DP
DS DP
NCE
ODE
DS DP
DS DP
NCE
ODE
M-151
M-151
M-151
M-151
M-156
04,
11,
15,
15,
2019
2023
2023
2023
DS
U-1695
U-1695
DP
DP
DP U-1666
LEVETIRACETAM - SPRITAM
N 207958 001
6471992
DP
LEVETIRACETAM - SPRITAM
N 207958 002
6471992
DP
LEVETIRACETAM - SPRITAM
N 207958 003
6471992
DP
A - 36
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
LEVETIRACETAM - SPRITAM
N 207958 004
6471992
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP
PC
PC
LEVONORGESTREL - LILETTA
N 206229 001
NP
LINEZOLID - LINEZOLID
A 078061 001
PC
LINEZOLID - LINEZOLID
A 200222 001
PC
DP
DP
DP
DP
DP
DP
DP
DP
DP
LINACLOTIDE - LINZESS
N 202811 001
8933030
DP
LINACLOTIDE - LINZESS
N 202811 002
8933030
DP
LINAGLIPTIN - TRADJENTA
N 201280 001
8673927
8853156
U-1503
U-1642
DP
DP
DP
LINEZOLID - ZYVOX
N 021131 002
6559305
6559305*PED
U-1503
U-1503
U-1503
DS
A - 37
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
LINEZOLID - ZYVOX
N 021131 003
6559305
6559305*PED
Aug
Aug
Jan
Aug
Aug
Aug
Jan
Oct
Jun
Jul
Jan
Feb
22,
22,
01,
22,
03,
13,
02,
20,
27,
17,
26,
01,
2022
2017
2022
2017
2026
2025
2022
2025
2022
2026
2026
2032
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
24,
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
2023
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DS
DP
DS DP U-1255
DS DP U-1255
DP
DS DP
DP
DP
DP
DP
DP
DP
DP
DP
U-727
I-703
I-703
I-703
I-703
DP
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
U-727
DP
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
U-727
DP
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
U-727
U-842
DP
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
A - 38
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
U-842
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
I-703
24,
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
2023
U-727
U-842
I-703
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
I-703
DP
U-727
DP U-842
U-842
DP U-842
DP U-842
DP
DP
DS
DS DP U-727
U-1034
DS
U-727
DP U-727
U-727
DP U-842
U-842
DP
DP
DP U-842
DP
U-727
DP U-842
DS
U-1317
DS
U-1317
DS
U-1317
Feb
Dec
Aug
Mar
21,
10,
19,
07,
2016
2019
2027
2025
DS
U-1317
U-1318
U-1316
U-1316
NCE
ODE
Feb
Dec
Aug
Mar
21,
10,
19,
07,
2016
2019
2027
2025
DS
U-1317
U-1318
U-1316
U-1316
NCE
ODE
Feb
Dec
Aug
Mar
21,
10,
19,
07,
2016
2019
2027
2025
DS
U-1317
U-1318
U-1316
U-1316
NCE
ODE
A - 39
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
Feb
Dec
Aug
Mar
LORATADINE - CLARITIN
N 020641 002
6132758
DP
Jun
Dec
Dec
Dec
Dec
Feb
Feb
Feb
2024
2025
2025
2025
2025
2033
2033
2033
DP
LOXAPINE - ADASUVE
N 022549 001
8955512
8991387
DP
DP
LULICONAZOLE - LUZU
N 204153 001
8980931
9012484
DP
DS DP U-540
DS
DS
DS
DS
DS
Apr
Apr
Apr
Apr
21,
10,
19,
07,
16,
20,
20,
20,
20,
07,
07,
07,
22,
22,
22,
22,
2016
2019
2027
2025
2024
2024
2024
2024
DS
U-1317
U-1318
U-1316
U-1316
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
NCE
ODE
EXCLUSIVITY
EXPIRATION
DATE
U-1252
U-1253
U-1254
U-1255
U-1688
U-1689
U-1692
U-755
DP U-755
U-755
U-755
MELOXICAM - VIVLODEX
N 207233 001
>A> NP
MELOXICAM - VIVLODEX
N 207233 002
>A> NP
MESALAMINE - ASACOL HD
N 021830 001
9089492
DP
MESALAMINE - APRISO
N 022301 001
8940328
8956647
DP
DP
A - 40
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DP U-1442
METHOTREXATE - OTREXUP
N 204824 002
8945063
DP U-1442
METHOTREXATE - OTREXUP
N 204824 003
8945063
DP U-1442
METHOTREXATE - OTREXUP
N 204824 004
8945063
DP U-1442
METHOTREXATE - OTREXUP
N 204824 005
8945063
DP U-1442
METHYLPHENIDATE - DAYTRANA
N 021514 001
9034370
DP
METHYLPHENIDATE - DAYTRANA
N 021514 002
9034370
DP
METHYLPHENIDATE - DAYTRANA
N 021514 003
9034370
DP
METHYLPHENIDATE - DAYTRANA
N 021514 004
9034370
DP
2017
2017
2018
2017
2017
2017
2017
2017
2018
2017
2017
2017
2017
2017
2018
2017
2017
2017
U-666
U-1693
DP U-666
U-1747
U-1748
U-666
U-1693
DP U-666
U-1747
U-1748
U-666
U-1693
DP U-666
U-1747
U-1748
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
A - 41
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-666
U-1693
DP U-666
U-1747
U-1748
DP U-666
U-1747
U-1748
DP U-1665
DP
DP
DP
DP
DP
DP
DP
NP
DP
DP
DP
DP
DP
DP
NP
DP
DP
DP
DP
DP
DP
NP
DP
DP
DP
DP
DP
DP
NP
DP
DP
DP
DP
DP
DP
NP
DP
DP
DP
NP
U-666
U-1693
A - 42
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP
DP
METRONIDAZOLE - NUVESSA
N 205223 001
7893097
8658678
8877792
8946276
Feb
Jun
Feb
Jun
MIFEPRISTONE - KORLYM
N 202107 001
8921348
19,
27,
02,
28,
2028
2028
2028
2032
U-1682
DP
U-1664
U-1643
U-282
DP
DP U-702
DP
DP
DP
DP
DP
EXCLUSIVITY
CODE(S)
NP
DP
PATENT
DELIST
REQUESTED
U-1640
U-1640
U-1640
U-1640
U-1640
EXCLUSIVITY
EXPIRATION
DATE
A - 43
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
EXCLUSIVITY
EXPIRATION
DATE
DP
DP U-1185
DS DP
DP U-1185
DS DP
Mar
Feb
Feb
Nov
2026
2031
2031
2024
EXCLUSIVITY
CODE(S)
U-1640
31,
28,
28,
23,
PATENT
DELIST
REQUESTED
U-540
DP
DP
DP
DP
8022095
Aug 14, 2017
8022095*PED
Feb 14, 2018
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET
N 021926 002
5872145
Aug 14, 2017
5872145*PED
Feb 14, 2018
6060499
Aug 14, 2017
6060499*PED
Feb 14, 2018
6586458
Aug 14, 2017
6586458*PED
Feb 14, 2018
DP U-867
DP U-867
DP U-867
DP U-867
DP U-1719
DP U-1719
DP U-1719
NP
PED
A - 44
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
EXCLUSIVITY
CODE(S)
DP
DP
NICOTINE - NICODERM CQ
N 020165 004
8999379
U-1686
NICOTINE - NICODERM CQ
N 020165 005
8999379
U-1686
NICOTINE - NICODERM CQ
N 020165 006
8999379
U-1686
DP
DP
U-1677
U-1677
>A> M-167
Apr
Oct
Oct
Aug
Sep
Aug
Mar
29,
11,
11,
12,
24,
04,
12,
2022
2024
2024
2027
2028
2031
2024
EXCLUSIVITY
EXPIRATION
DATE
DP U-1719
OLAPARIB - LYNPARZA
N 206162 001
7151102
7449464
7981889
8143241
8247416
8859562
8912187
PATENT
DELIST
REQUESTED
DS DP
DS DP
DS DP
ODE
NC
NCE
U-1634
DS
U-1634
U-1634
DP
DP
A - 45
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
- TECHNIVIE
Jun 26, 2016
Dec 26, 2016
Jun 26, 2016
Dec 26, 2016
Jul 19, 2019
Jan 19, 2020
Nov 10, 2020
May 10, 2021
Aug 25, 2024
Feb 25, 2025
Aug 25, 2024
Feb 25, 2025
Apr 10, 2031
Oct 10, 2031
Sep 10, 2029
Jun 09, 2031
Apr 13, 2032
Jun 10, 2030
Apr 10, 2031
Feb
Jan
Jan
Feb
OMEPRAZOLE - OMEPRAZOLE
N 022032 001
9023391
DP
ONDANSETRON - ZUPLENZ
N 022524 001
9095577
DP
ONDANSETRON - ZUPLENZ
N 022524 002
9095577
DP
OSPEMIFENE - OSPHENA
N 203505 001
8642079
OXCARBAZEPINE - OXTELLAR XR
N 202810 001
9119791
07,
04,
04,
07,
2025
2033
2033
2025
DP U-1680
NP
PED
U-1635
NCE
NP
U-1635
DP
DP
DP
DP
DS DP
DS DP U-1638
DP
DS DP
U-1687
U-1638
DP U-1511
U-1511
DS
DP U-1511
DS DP U-1113
DP
U-1298
A - 46
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
OXCARBAZEPINE - OXTELLAR XR
N 202810 002
9119791
U-1298
OXCARBAZEPINE - OXTELLAR XR
N 202810 003
9119791
U-1298
U-1644
DS
DS
DS
DS
DS
DS
DS
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP
M-153
NPP
DP
M-153
NPP
DP
M-153
NPP
DP
M-153
NPP
DP
M-153
NPP
DP
M-153
NPP
DP
M-153
NPP
NCE
NCE
NCE
NP
PACLITAXEL - ABRAXANE
N 021660 001
9101543
PALBOCICLIB - IBRANCE
N 207103 001
6936612
7208489
7456168
DS DP
DS DP
PALBOCICLIB - IBRANCE
N 207103 002
6936612
7208489
7456168
DS DP
DS DP
PALBOCICLIB - IBRANCE
N 207103 003
6936612
7208489
7456168
DS DP
DS DP
PATENT
DELIST
REQUESTED
U-1434
U-1658
U-1658
U-1658
DP U-543
A - 47
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT
EXPIRATION
DATE
PATENT NO
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-543
NP
DP U-543
NP
DP U-543
NP
DP U-528
DP
DP
DP
DP
Aug
Sep
Aug
Jan
Jun
31,
30,
31,
17,
13,
2021
2021
2021
2028
2028
DS DP
DS DP U-1669
U-1669
DS DP
U-1669
NCE
ODE
Aug
Sep
Aug
Jan
Jun
31,
30,
31,
17,
13,
2021
2021
2021
2028
2028
DS DP
DS DP U-1669
U-1669
DS DP
U-1669
NCE
ODE
Aug
Sep
Aug
Jan
Jun
31,
30,
31,
17,
13,
2021
2021
2021
2028
2028
DS DP
DS DP U-1669
U-1669
DS DP
U-1669
NCE
ODE
>A> NCE
>A> NCE
>A> NCE
DS DP U-904
PERAMPANEL - FYCOMPA
N 202834 001
I-710
PERAMPANEL - FYCOMPA
N 202834 002
I-710
A - 48
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
PERAMPANEL - FYCOMPA
N 202834 003
I-710
PERAMPANEL - FYCOMPA
N 202834 004
I-710
PERAMPANEL - FYCOMPA
N 202834 005
I-710
PERAMPANEL - FYCOMPA
N 202834 006
I-710
POMALIDOMIDE - POMALYST
N 204026 001
I-707
POMALIDOMIDE - POMALYST
N 204026 002
I-707
POMALIDOMIDE - POMALYST
N 204026 003
I-707
POMALIDOMIDE - POMALYST
N 204026 004
I-707
DP
DP
DP
DP
U-1262
U-1262
U-1262
U-1262
PIRFENIDONE - ESBRIET
N 022535 001
7696236
U-1601
POLIDOCANOL - VARITHENA
N 205098 001
RE40640
DS DP U-1462
Dec
Dec
Dec
Dec
Dec
22,
22,
22,
22,
22,
2026
2026
2026
2026
2026
U-836
U-1283
U-1699
U-1700
U-1701
Dec
Dec
Dec
Dec
Dec
22,
22,
22,
22,
22,
2026
2026
2026
2026
2026
U-836
U-1283
U-1699
U-1700
U-1701
A - 49
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
Dec
Dec
Dec
Dec
Dec
2026
2026
2026
2026
2026
U-836
U-1283
U-1699
U-1700
U-1701
POSACONAZOLE - NOXAFIL
N 205596 001
9023790
DP U-1698
PREDNISONE - RAYOS
N 202020 001
9040085
U-1362
PREDNISONE - RAYOS
N 202020 002
9040085
U-1362
PREDNISONE - RAYOS
N 202020 003
9040085
U-1362
REGADENOSON - LEXISCAN
N 022161 001
9045519
9085601
DP
DP
REGORAFENIB - STIVARGA
N 203085 001
8637553
8680124
DS DP
RIFAXIMIN - XIFAXAN
N 022554 001
6861053
6861053
7452857
7452857
7605240
7605240
7718608
7718608
7915275
7915275
7935799
7935799
8193196
8193196
8309569
8309569
8741904
8741904
8741904
8946252
8969398
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Feb
Aug
Aug
Sep
Sep
Jul
Jul
Feb
Feb
Feb
Jul
Oct
2019
2019
2019
2019
2019
2019
2019
2019
2025
2025
2019
2019
2027
2027
2029
2029
2026
2026
2026
2029
2029
U-1707
U-1708
U-1707
U-1708
U-1707
U-1708
U-1707
U-1708
U-1707
U-1708
U-1707
U-1708
DS DP U-1707
DS DP U-1708
U-1707
U-1708
DS
U-1526
DS
U-1707
DS
U-1708
U-1481
U-1481
I-709
DS DP U-1153
DS DP U-1307
DS DP U-1740
NPP
PC
PC
22,
22,
22,
22,
22,
11,
11,
11,
11,
11,
11,
11,
11,
23,
23,
11,
11,
02,
02,
18,
18,
27,
27,
27,
24,
02,
U-1506
A - 50
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
PC
RIVASTIGMINE - RIVASTIGMINE
A 204403 003
PC
NCE
NCE
NCE
NCE
ROFLUMILAST - DALIRESP
N 022522 001
5712298
DS DP U-1115
Dec
Apr
Apr
Apr
Apr
Oct
Oct
Jan
Dec
2023
2027
2027
2027
2027
2029
2029
2029
2022
DS DP U-1741
DP
U-1741
U-1742
DS DP
DP
U-1741
U-1741
U-1741
U-1573
U-1721
U-1573
U-1721
U-1573
U-1721
U-1573
U-1721
U-1573
U-1721
Nov
Jan
Jan
Jan
May
27,
14,
14,
14,
27,
2023
2023
2023
2023
2027
Nov
Jan
Jan
Jan
May
27,
14,
14,
14,
27,
2023
2023
2023
2023
2027
Nov
Jan
Jan
Jan
May
27,
14,
14,
14,
27,
2023
2023
2023
2023
2027
08,
04,
04,
04,
04,
09,
09,
18,
17,
DP
DP
DP
U-1723
DS DP
DP
DP
DP
U-1723
DS DP
DP
DP
DP
U-1723
DS DP
A - 51
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
DS DP U-1467
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
>A> D-151
>A> I-717
EXCLUSIVITY
EXPIRATION
DATE
SIROLIMUS - RAPAMUNE
N 021083 001
ODE
SIROLIMUS - RAPAMUNE
N 021110 001
ODE
SIROLIMUS - RAPAMUNE
N 021110 002
ODE
SIROLIMUS - RAPAMUNE
N 021110 003
ODE
SIROLIMUS - RAPAMUNE
N 021110 004
ODE
NCE
U-1101
U-1102
U-1532
SOFOSBUVIR - SOVALDI
N 204671 001
9085573
DS DP U-1470
DP
DP
DP
DP
DP
DP
DP
DP
DP
U-1041
DS DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP
DS DP
DS
U-1722
U-1459
U-1696
A - 52
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
SPINOSAD - NATROBA
N 022408 001
6063771
DP U-1670
DP U-1328
TACROLIMUS - ENVARSUS XR
N 206406 001
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186
Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024
TACROLIMUS - ENVARSUS XR
N 206406 002
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186
Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
TACROLIMUS - ENVARSUS XR
N 206406 003
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186
Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
M-152
DP
DP U-1752
U-1752
DP
DP
DP
U-1752
U-1752
DP U-1752
U-1752
U-1752
ODE
2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024
DP
DP U-1752
U-1752
DP
DP
DP
U-1752
U-1752
DP U-1752
U-1752
U-1752
ODE
2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024
DP
DP U-1752
U-1752
DP
DP
DP
U-1752
U-1752
DP U-1752
U-1752
U-1752
ODE
U-1739
U-1739
U-1739
U-1739
U-1739
TASIMELTEON - HETLIOZ
N 205677 001
9060995
U-1710
A - 53
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
DS DP U-1320
U-1320
TESTOSTERONE - ANDROGEL
N 021015 001
9125816
9132089
U-490
U-490
TESTOSTERONE - ANDROGEL
N 021015 002
9125816
9132089
U-490
U-490
TESTOSTERONE - ANDROGEL
N 021015 003
9125816
9132089
U-490
U-490
TESTOSTERONE - ANDROGEL
N 022309 001
9125816
9132089
U-1103
U-1103
TESTOSTERONE - ANDROGEL
N 022309 002
9125816
9132089
U-1103
U-1103
TESTOSTERONE - ANDROGEL
N 022309 003
9125816
9132089
U-1103
U-1103
TESTOSTERONE - AXIRON
N 022504 001
8435944
8993520
U-1390
U-1390
TICAGRELOR - BRILINTA
N 022433 001
I-714
TICAGRELOR - BRILINTA
N 022433 002
6251910
6525060
7250419
7265124
>A> 8425934
Jul
Dec
Dec
Jul
Apr
TIGECYCLINE - TYGACIL
N 021821 001
8975242
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
15,
02,
02,
09,
17,
04,
16,
31,
05,
04,
28,
28,
23,
04,
31,
26,
10,
26,
2018
2019
2019
2021
2030
2016
2016
2016
2016
2016
2018
2018
2020
2016
2016
2024
2026
2019
EXCLUSIVITY
EXPIRATION
DATE
DS
DS DP U-1171
DS DP U-1171
DS DP U-1171
DP
>A> NCE
NS
NP
A - 54
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
13,
26,
04,
16,
31,
30,
LONSURF
28, 2016
16, 2020
16, 2026
DS DP U-1751
U-1751
U-1751
NCE
LONSURF
28, 2016
16, 2020
16, 2026
DS DP U-1751
U-1751
U-1751
NCE
TOPIRAMATE - TROKENDI XR
N 201635 001
8298576
8992989
DP U-106
DP U-1675
TOPIRAMATE - TROKENDI XR
N 201635 002
8298576
8992989
DP U-106
DP U-1675
TOPIRAMATE - TROKENDI XR
N 201635 003
8298576
8992989
DP U-106
DP U-1675
TOPIRAMATE - TROKENDI XR
N 201635 004
8298576
8992989
DP U-106
DP U-1675
TOPIRAMATE - QUDEXY XR
N 205122 001
9101545
DP
TOPIRAMATE - QUDEXY XR
N 205122 002
9101545
DP
TOPIRAMATE - QUDEXY XR
N 205122 003
9101545
DP
TOPIRAMATE - QUDEXY XR
N 205122 004
9101545
DP
TOPIRAMATE - QUDEXY XR
N 205122 005
9101545
DP
>A> NCE
2028
2025
2021
2029
2027
2018
DP
DP
DP
DP
DP
DS DP
TRABECTEDIN - YONDELIS
N 207953 001
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 001
8703781
Oct 15, 2030
DS DP U-1712
DS DP U-1712
DS DP U-1712
A - 55
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT
EXPIRATION
DATE
PATENT NO
PATENT
CODES
DP U-1182
DP
DP
DP
DS DP
DS DP
DS DP
DS DP
DS
DS DP
DS
DS DP
DS
DS DP
DS
DS DP
TRETINOIN - RETIN-A-MICRO
N 020475 003
5955109
DP U-134
DP
TRAVOPROST - IZBA
N 204822 001
8178582
9144561
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
U-1657
DP
NCE
ODE
D-148
NPP
D-148
NPP
D-146
A - 56
PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO
PATENT NO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
D-146
D-146
ZOLMITRIPTAN - ZOMIG
N 021450 003
NPP
ZOLMITRIPTAN - ZOMIG
N 021450 004
NPP
DS DP
DS DP
DS DP
DS DP
U-1668
U-1668
U-1668
U-1668
Footnote:
1. Patents are published upon receipt by the Orange book Staff and may not reflect the official receipt date as
2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and
submitted by the sponsor. They may not be flagged with respect to other claims which may apply.
B-1