Attachment II Sample 356h
Attachment II Sample 356h
Attachment II Sample 356h
Attachment II
Sample Formats
Form FDA 356h
for
Ammonia N 13 Injection
Fludeoxyglucose F 18 Injection (FDG F 18)
and
Sodium Fluoride F 18 Injection
Date: 25-Jan-2011
Form Approved: OMS No. 0910-0338 Expiration Date: September 30, 2008 See OMS Statement on page 2.
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE
(Title 21, Code of Federal Regulations, Parts 314 & 601)
APPLICANT INFORMATION
NAME OF APPLICANT
I TELEPHONE NO. (Include I
DATE OF SUBMISSION
II
Area Code)
I
AUTHORIZED U.S. AGENT NAME & FACSIMILE (FAX Number (Include
Area Code)
I I
APPLICANT ADDRESS (Number, Street, City, State, Country, zip Code or Mail Code, and U.S. License number if oreviouslv issued):
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) PROPRIETARY NAME (trade name) IF ANY ESTABLISHED NAME Ie.". Proner name USP/USAN name)
I I
IFludeoxyglucose F 18 Injection
CHEMICAL/BIOCHEMICAL/BLOOD PRODUCT NAME (If anv)
liinone
CODE NAME (If any!
I
I
pOSAGE FORM'
Injection I
ROUTE OF ADMINISTRATION:
)1 I STRENGTHS:
I I
Intravenous I
(PROPOSED) INDICATION(S) FOR USE: lin Positron Emission Tomography for ...
I
APPLICATION DESCRIPTION
APPLICATION TYPE .
12SOS (b)(2)
DSOS(b)(1) IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
DCBE
DCBE-30
THIS APPLICATION IS
DpAPER
D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment information should be provided In the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps and/or type of testing (e.g. Final dosage form, Stabilty testing)
conducted at the site. Please .indicate whether the site is ready for inspection or, if not, when it wil be ready.
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
PAGE 1 OF4
This application contains the following items: (Check all that apply)
0 0 0
D D
1. Index
Draft Labeling
4. Chemistry section
A.
B.
Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)
Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)
c.
5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)
6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)
0 0 0 0 0 0
0
0 0
12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
13. Patent information on any patent which claims the drug (21 U.S.C. 355(b) or (c))
14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or )(2)(A))
CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, I agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
"
3. Labeling regulations in 21 CFR Parts 201, 606, 610,660, and/or 809. 4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81.
7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A wilfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT
I II TYPED NAME AND TITLE
JI rATE:
I Telephone Number
II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville, MD 20705-1266
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (HFM-99) 1401 Rockville Pike Rockville, MD 20852-1448
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a
currently valid OMB control number.
PAGE 2 OF 4
Form Approved: OMB No. 0910-0338 Expiration Date: September 30, 2008 See OMB Statement on page 2.
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE
(Title 21, Code of
APPLICATION NUMBER
APPLICANT INFORMATION
NAME OF APPLICANT
I TELEPHONE NO. (Include I
DATE OF SUBMISSION
II
Area Code)
I
APPLICANT ADDRESS (Number, Street, City, State, Country, zip Code or Mail Code, and U.S. LIcense number if oreviouslv issued!:
AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State,
ZiP Code, telephone & FAX number) IF APPLICABLE
I I
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued)
Iinone
CODE NAME (If any)
I
pOSAGE FORM'
Injection i
ROUTE OF ADMINISTRATION:
IISTRENGTHS:
Intravenous I i I
APPLICATION DESCRIPTION
APPLICATION TYPE
(check one) IZNEW DRUG APPLICATION (CDA, 21 CFR 314.S0)
DS05(b)(1)
0S0S (b)(2)
IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
DCBE
DCBE-30
THIS APPLICATION IS
DPAPER
D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment information should be provided In the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps andlor type of testing (e.g. Final dosage form, Stability testing)
conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it wil be ready.
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
FORM FDA
356h (10/05)
PAGE 1 OF4
This application contains the following items: (Check all that apply)
0 0 0
0
IZ IZ
1. Index
o Draft Labeling
A.
B.
Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)
C.
0 0 0 0 0 0 0 0
IZ IZ
5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)
6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)
13. Patent information on any patent which claims the drug (21 U.S.C. 355(b) or (c))
14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or U)(2)(A))
0 IZ
0 0
CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, i agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81.
7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
I DATE:
III
I Telephone Number
II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
PAGE20F4
Form Approved: OMB No. 0910-0338 Expiration Date: September 30, 2008 See OMS Statement on page 2. FOR FDA USE ONLY
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE
(Tite 21, Code of Federal Regulations, Parts 314 & 601)
APPLICANT INFORMATION
NAME OF APPLICANT
I TELEPHONE NO. (Include I
APPLICATION NUMBER
DATE OF SUBMISSION
II
Area Code)
I FACSIMILE (FAX) Number (Include
Area Code)
I I
APPLICANT ADDRESS (Number, Street, City, State, Country, zip Code or Mail Code, and U. S. License number if Dreviouslv issued):
AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State, ZiP Code, telephone & FAX number) IF APPLICABLE
I I
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) I I PROPRIETARY NAME Itrade name) IF ANY ESTABLISHED NAME (e.a. ProDer name USP/USAN name)
I
IIAmmonia N 13 Injection
CHEMICALIBIOCHEMICAL/BLOOD PRODUCT NAME (If anv)
II
Illnone
CODE NAME (If any!
II
pOSAGE FORM'
Injection
I STRENGTHS:
ROUTE OF ADMINISTRATION:
Intravenous I I I
III
APPLICATION DESCRIPTION
APPLICATION TYPE
(check one) NEW DRUG APPLICATION (CDA, 21 CFR 314.50) o ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)
DSOS(b)(1)
50S (b)(2)
I I
IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
Name of Drug I I Holder of Approved Application
TYPE OF SUBMISSION (check oneb ORIGINAL APPLICATION . DAMENDMENTTO APENDING APPLICATION. DRESUBMISSION
o PRESUBMISSION ~ ANNUAL REPORT DESTABLISHMENT DESCRIPTION SUPPLEMENT o CHEMISTRY MANUFACTURING DLABELING SUPPLEMENT o
EFFICACY SUPPLEMENT .
DCBE
DCBE-30
THIS APPLICATION IS
DpAPER
D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment Information should be provided in the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps andlor type of testing (e.g. Final dosage form, Stability testing)
conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it will be ready.
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
PAGE 1 OF 4
This application contains the following items: (Check all that apply)
0
12 0 0 IZ 0 0 0 D 0 D 0 0
0 0
0
0 0
1. Index
2. Labeling (check one)
Draft Labeling
4. Chemistry section
A.
B.
Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)
Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)
C.
5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)
6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)
14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or )(2)(A))
15. Establishment description (21 CFR Part 600, if applicable)
19. Financial
CERTIFICATION
i agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. i agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, i agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210,211 or applicable regulations, Parts 606, and/or 820. 2. Biological establishment standards in 21 CFR Part 600. 3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809. 4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81. 7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, i agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A wilfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT
il rATE:
I Teleohone Number
II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Central Document Room
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
PAGE20F4