Competitive Generic Therapy Approvals
The Office of Generic Drugs is providing a public list of all approved abbreviated new drug application (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and is also noting which ANDAs on this list cover drug products that were also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act. This list will be updated on a bi-weekly basis with new ANDA approvals where at least one of the drug products, i.e., one of the strengths, in the approved application received a CGT designation.
The Agency is including the following information for individual drug products on the CGT Approvals List:
- Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
This column reflects the proprietary name, if any, of the RLD and its NDA number. - ANDA Number
- ANDA Applicant
- Active Ingredient Name, Dosage Form, Strength
This column reflects the established (nonproprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s). - Date of Approval
This column indicates the date on which an ANDA for a CGT-designated drug product(s) received final approval. - Eligible for CGT Exclusivity
In this column, drug products that, at the time of approval, were eligible for CGT exclusivity will be indicated with a “Yes,” while drug products that were not eligible for CGT exclusivity at the time of approval will be indicated with a “No.” Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act. There is only one exclusivity period available for each CGT, and receiving a CGT designation does not ensure that a drug product will be eligible for CGT exclusivity. For example, a drug product in an ANDA that receives a CGT designation will not be eligible for CGT exclusivity if there were unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA for the CGT-designated drug product. - CGT Exclusivity Forfeiture
This column indicates whether or not a drug product that was eligible for CGT exclusivity upon approval forfeited eligibility because it was not commercially marketed within 75 days after the date of approval of the ANDA (see section 505(j)(5)(D)(iv) of the FD&C Act). A forfeiture event is indicated with “Yes.” Non-forfeiture is indicated with “No.” If the forfeiture determination has not yet been made, the column will be blank, and if the CGT was not eligible for exclusivity upon approval, the column will reflect “N/A.” If the first approved applicant has voluntarily relinquished the CGT exclusivity, the column will reflect “Relinquished.” - Date of First Commercial Marketing of CGT with Exclusivity
This column reflects the date of first commercial marketing of a CGT by a first approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit its eligibility. The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant. This 180-day CGT exclusivity period, once triggered, blocks the approval of an ANDA for a drug that is the same as the CGT. If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column will reflect “N/A.”
FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity. FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT). By providing the commercial marketing start date for CGT exclusivity periods, this list will also provide useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity regarding when the exclusivity period will expire. To note, FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section of the Orange Book for the approved drug products eligible for 180-day CGT exclusivity upon any first approved applicant’s commercial marketing, indicating the date the 180-day CGT exclusivity will expire.
Competitive Generic Therapy Approvals
No. | RLD Name and NDA Number | ANDA Number | ANDA Applicant | Active Ingredient Name, Dosage Form, Strength | Date of Approval | Eligible for CGT Exclusivity | CGT Exclusivity Forfeiture | Date of First Commercial Marketing of CGT with Exclusivity | |
---|---|---|---|---|---|---|---|---|---|
318 | Ingrezza, NDA 209241 | 216137 | Zydus Worldwide DMCC | Valbenazine Capsules, 40 mg, 60 mg and 80 mg | 8/7/2024 | No | N/A | N/A | |
317 | Pred Forte, NDA 17011 | 216935 | Lupin Limited | Prednisolone Acetate Ophthalmic Suspension USP, 1% | 8/2/2024 | Yes | |||
316 | Carafate Oral Suspension, NDA 19183 | 212769 | Hikma Pharmaceuticals USA Inc. | Sucralfate Oral Suspension, 1 g/10 mL | 7/23/2024 | No | N/A | N/A | |
315 | Thiola EC, NDA 211843 | 216456 | Teva Pharmaceuticals Inc. | Tiopronin Delayed-Release Tablets, 100 mg and 300 mg | 7/22/2024 | No | N/A | N/A | |
314 | Halaven, NDA 201532 | 214850 | Long Grove Pharmaceuticals LLC | Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vials | 7/18/2024 | No | N/A | N/A | |
313 | Zinc Sulfate, NDA 209377 | 216135 | Somerset Therapeutics LLC | Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package | 7/17/2024 | No | N/A | N/A | |
312 | Tazorac, NDA 21184 | 217075 | Padagis Israel Pharmaceuticals Ltd. | Tazarotene Cream, 0.05% | 7/15/2024 | Yes | N/A | N/A | |
311 | Divigel, NDA 022038 | 216055 | Amneal Pharmaceuticals LLC | Estradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet) | 7/12/2024 | No | N/A | N/A | |
310 | Potassium Phosphates, NDA 212832 | 217726 | Somerset Therapeutics LLC | Potassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials | 7/11/2024 | No | N/A | N/A | |
309 | Alrex, NDA 20803 | 215203 | Padagis US LLC | Loteprednol Etabonate Ophthalmic Suspension, 0.2% | 7/10/2024 | No | N/A | ||
308 | Endari, NDA 208587 | 215647 | Novitium Pharma LLC | L-Glutamine Oral Powder, 5 grams/packet | 7/8/2024 | No | N/A | N/A | |
307 | Zinc Sulfate, NDA 209377 | 214597 | Nivagen Pharmaceuticals, Inc | Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL), 25 mg/5 mL (5 mg/mL) and 10 mg/10 mL (1 mg/mL) Pharmacy Bulk Package | 7/5/2024 | No | N/A | N/A | |
306 | Atropine Sulfate, NDA 214652 | 215969 | Somerset Therapeutics LLC | Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials | 7/3/2024 | No | N/A | N/A | |
305 | Exparel, NDA 22496 | 214348 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Bupivacaine Liposome Injectable Suspension, 133 mg/10 mL (13.3 mg/mL) and 266 mg/20 mL (13.3 mg/mL) Single -dose Vials | 7/1/2024 | No | N/A | N/A | |
304 | Atropine Sulfate, NDA 206289 | 215618 | Somerset Therapeutics LLC | Atropine Sulfate Ophthalmic Solution USP, 1% | 7/1/2024 | No | N/A | N/A | |
303 | Astepro OTC, NDA 213872 | 216576 | ANDA Applicant |
Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy) | 6/5/2024 | No | N/A | N/A | |
302 | Astepro OTC, NDA 213872 | 216421 | Apotex Inc. | Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy and Children's Allergy) | 5/29/2024 | No | N/A | N/A | |
301 | Halog, 17823 | 217671 | Encube Ethicals Private Limited | Halcinonide Topical Solution USP, 0.1% | 5/29/2024 | Yes | Yes | N/A | |
300 | Phenylephrine, NDA 207926 | 215183 | Caplin Steriles Limited | Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% and 10% | 5/23/2024 | No | N/A | N/A | |
299 | Timolol Maleate, NDA 20963 | 216343 | Amneal EU, Limited | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% | 5/23/2024 | Yes | Yes | N/A | |
298 | Somatuline Depot, NDA 22074 | 217193 | InvaGen Pharmaceuticals, Inc. | Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL, Single-Dose Prefilled Syringes | 5/21/2024 | No | N/A | N/A | |
297 | ProAir HFA, NDA 21457 | 212447 | Armstrong Pharmaceuticals Inc. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (base) per actuation | 5/21/2024 | No | N/A | N/A | |
296 | Calcium Gluconate in Sodium Chloride, NDA 208418 | 216611 | Amneal EU, Limited | Calcium Gluconate Injection USP, 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials (10 mL Fill) and Calcium Glconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill) | 5/10/2024 | No | N/A | N/A | |
295 | Zegerid OTC, NDA 22283 | 217784 | Dr. Reddy's Laboratories Limited | Omeprazole and Sodium Bicarbonate Powder for Oral Suspension, 20 mg/1680 mg (OTC) | 5/9/2024 | Yes | Yes | N/A | |
294 | Dexamethasone, NDA 88306 | 216284 | Zydus Pharmaceuticals (USA) Inc. | Dexamethasone Tablets USP, 1 mg | 5/9/2024 | No | N/A | N/A | |
293 | Vasostrict, NDA 204485 | 213988 | Dr. Reddy's Laboratories Limited | Vasopressin Injection USP, 20 Units/mL Single-Dose Vials | 5/8/2024 | No | N/A | N/A | |
292 | Radicava, NDA 209176 | 218354 | Long Grove Pharmaceuticals LLC | Edaravone Injection, 30 mg/100 ml (0.3 mg/mL), Single-Dose Bag | 5/6/2024 | No | N/A | N/A | |
291 | Radicava, NDA 209176 | 215917 | Dr. Reddy's Laboratories Limited | Edaravone Injection, 60 mg/100 ml (0.6 mg/mL), Single-Dose Bag | 5/6/2024 | No | N/A | N/A | |
290 | Cupric Chloride in Plastic Container, NDA 18960 | 217626 | Stira Pharmaceuticals LLC | Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials | 4/30/2024 | Yes | N/A | N/A | |
289 | Cupric Chloride in Plastic Container, NDA 18960 | 216113 | Somerset Therapeutics | Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials | 4/30/2024 | Yes | N/A | 6/24/2024 | |
288 | Isopto Atropine, NDA 208151 | 217791 | Somerset Therapeutics | Atropine Sulfate Ophthalmic Solution USP, 1% | 4/29/2024 | Yes | No | 6/7/2024 | |
287 | Nasonex, NDA 215712 | 217438 | Apotex Inc. | Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC) | 4/23/2024 | No | N/A | N/A | |
286 | Votrient, NDA 22465 | 218231 | Novugen Oncology Sdn. Bhd. | Pazopanib Tablets, 200 mg | 4/23/2024 | No | N/A | N/A | |
285 | EstroGel, NDA 21166 | 216160 | Solaris Pharma Corporation | Estradiol Gel, 0.06% | 4/22/2024 | Yes | No | 4/26/2024 | |
284 | Tranexamic Acid, NDA 212020 | 216877 | Nexus Pharmaceuticals LLC | Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) | 4/16/2024 | No | N/A | N/A | |
283 | Miacalcin, NDA 017808 | 215715 | Dr. Reddy's Laboratories Limited | Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial | 4/11/2024 | No | N/A | N/A | |
282 | Oracea, NDA 218034 | 218034 | Dr. Reddy's Laboratories Limited | Doxycycline Capsules, 40 mg | 4/8/2024 | No | N/A | N/A | |
281 | Narcan, NDA 16636 | 213573 | Fresenius Kabi USA, LLC | Naloxone Hydrochloride Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Prefilled Syringe | 4/2/2024 | No | N/A | N/A | |
280 | Sodium Acetate, NDA 18893 | 216920 | Hikma Pharmaceuticals USA, Inc | Sodium Acetate Injection USP, 40 mEq/20 mL (2 mEq/mL) | 3/15/2024 | Yes | No | 5/20/2024 | |
279 | Entadfi, NDA 215423 | 218232 | Zydus Worldwide DMCC | Finasteride and Tadalafil Capsules, 5 mg/5 mg | 3/15/2024 | Yes | Yes | N/A | |
278 | Rectiv, NDA 21359 | 216103 | Cosette Pharmaceuticals, Inc | Nitroglycerin Ointment USP, 0.4% | 2/16/2024 | Yes | No | 2/23/2024 | |
277 | Lumify, NDA 208144 | 216361 | Dr. Reddy's Laboratories SA | Brimonidine Tartrate Ophthalmic Solution, 0.025% | 2/16/2024 | No | N/A | N/A | |
276 | Dilaudid, NDA 019034 | 216889 | Hikma Pharmaceuticals USA, Inc | Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL Single-Dose Prefilled Syringe | 2/9/2024 | No | N/A | N/A | |
275 | Dexamethasone, ANDA 087916 | 216283 | Zydus Pharmaceuticals (USA) Inc | Dexamethasone Tablets USP, 2 mg | 2/7/2024 | No | N/A | N/A | |
274 | Thiola EC, NDA 211843 | 216990 | Torrent Pharmaceuticals Ltd | Tiopronin Delayed-Release Tablets, 100 mg and 300 mg | 1/30/2024 | No | N/A | N/A | |
273 | Astagraf XL, NDA 204096 | 215012 | Chengdu Suncadia Medicine Co., Limited | Tacrolimus Extended-Release Capsules, 0.5 mg, 1 mg, and 5 mg | 1/25/2024 | No | N/A | N/A | |
272 | Carafate, NDA 019183 | 213549 | PD Partners III, LLC | Sucralfate Oral Suspension, 1 g/10 mL | 1/17/2024 | No | N/A | N/A | |
271 | BiDil, NDA 020727 | 215988 | i3 Pharmaceuticals, LLC | Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg | 1/17/2024 | No | N/A | N/A | |
270 | Nuplazid, NDA 210793 | 214493 | Zydus Pharmaceuticals (USA) Inc. | Pimavanserin Capsules, 34 mg | 1/16/2024 | No | N/A | N/A | |
269 | Nuplazid, NDA 207318 | 214502 | Zydus Pharmaceuticals (USA) Inc. | Pimavanserin Tablets, 10 mg | 1/16/2024 | No | N/A | N/A | |
268 | Indocin, NDA 018332 | 217883 | Novitium Pharma LLC | Indomethacin Oral Suspension, USP 25 mg/5 mL | 1/12/2024 | Yes | No | 1/12/2024 | |
267 | FML, NDA 016851 | 216348 | Amneal EU, Limited | Fluorometholone Ophthalmic Suspension USP, 0.1% | 1/9/2024 | Yes | No | 1/9/2024 | |
266 | Amicar, NDA 015230 | 213213 | Sunny Pharmtech Inc. | Aminocaproic Acid Oral Solution USP, 0.25 grams/mL | 12/27/2023 | No | N/A | N/A | |
265 | Alrex, NDA 020803 | 215550 | Lupin Limited | Loteprednol Etabonate Ophthalmic Suspension, 0.2% | 12/26/2023 | No | N/A | N/A | |
264 | Prezista, N021976 | 214085 | Zydus Pharmaceuticals (USA) Inc. | Darunavir Tablets, 800 mg | 12/13/2023 | No | N/A | N/A | |
263 | ProvayBlue, NDA 204630 | 215636 | Zydus Pharmaceuticals (USA) Inc. | Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and 50 mg/10 mL (5 mg/mL) Single-Dose Vials | 12/5/2023 | No | N/A | N/A | |
262 | Lotemax, NDA 202872 | 213956 | Slayback Pharma LLC | Loteprednol Etabonate Ophthalmic Gel, 0.5% | 11/29/2023 | No | N/A | N/A | |
261 | Foscavir, NDA 020068 | 213987 | Beijing Secure Pharmaceutical Co., Ltd. | Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion | 11/29/2023 | No | N/A | N/A | |
260 | Corlanor, NDA 206143 | 213442 | Zydus Pharmaceuticals (USA) Inc. | Ivabradine Tablets, 5 mg and 7.5 mg | 11/29/2023 | No | N/A | N/A | |
259 | Condylox, NDA 020529 | 211871 | Padagis US LLC | Podofilox Gel 0.5% | 11/22/2023 | Yes | No | 12/13/2023 | |
258 | Zovirax, NDA 021478 | 212361 | Alembic Pharmaceuticals Limited | Acyclovir Cream, 5% | 11/21/2023 | Yes | No | 12/15/2023 | |
257 | Revex, NDA 020459 | 216007 | Chengdu Shuode Pharmaceutical Co., Ltd. | Nalmefene Hydrochloride Injection, 100 mcg/mL and 2 mg/2 mL (1 mg/mL) Single-Dose Vials | 11/15/2023 | No | N/A | N/A | |
256 | Divigel, NDA 022038 | 216524 | Padagis Israel Pharmaceuticals Ltd. | Estradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet) | 11/14/2023 | No | N/A | N/A | |
255 | AN Sulfur Colloid, NDA 017858 | 213516 | Jubilant DraxImage Inc. | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection | 11/9/2023 | Yes | No | 12/4/2023 | |
254 | Efudex, NDA 016831 | 215612 | Encube Ethicals Private Limited | Fluorouracil Topical Solution USP, 5% | 11/2/2023 | Yes | Yes | N/A | |
253 | Aczone, NDA 207154 | 212657 | Padagis US LLC | Dapsone Gel, 7.5% | 11/1/2023 | No | N/A | N/A | |
252 | Principen, NDA 050056 | 216554 | Aurobindo Pharma Limited | Ampicillin Capsules USP, 250 mg and 500 mg | 10/31/2023 | Yes | No | 12/11/2023 | |
251 | Calcium Gluconate in Sodium, NDA 208418 |
217689 | Somerset Therapeutics | Calcium Gluconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill) and Calcium Gluconate Injection USP, 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package (100 mL Fill) | 10/19/2023 | Yes - 5,000 mg/50 mL (100 mg/mL); No-10,000 mg/100 mL (100 mg/mL) | No | 10/20/2023 | |
250 | Votrient, NDA 022465 | 215837 | Sun Pharmaceutical Industries | Pazopanib Tablets, 200 mg | 10/19/2023 | No | N/A | N/A | |
249 | Votrient, NDA 022465 | 217517 | Teva Pharmaceuticals | Pazopanib Tablets, 200 mg | 10/19/2023 | No | N/A | N/A | |
248 | Tranexamic Acid, NDA 212020 | 217155 | Amneal Pharmaceuticals of New York, LLC | Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) | 10/16/2023 | Yes | No | 10/19/2023 | |
247 | Potassium Phosphates, NDA 212832 | 216344 | Amneal Pharmaceuticals of New York, LLC | Potassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials | 10/10/2023 | No | N/A | N/A | |
246 | Bridion, NDA 022225 | 214290 | Zydus Pharmaceuticals (USA) Inc. | Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vials | 10/4/2023 | No | N/A | N/A | |
245 | Glucotrol, NDA 017783 | 214874 | Rubicon Research Private Limited | Glipizide Tablets USP, 2.5 mg | 10/3/2023 | Yes | No | 10/18/2023 | |
244 | Potassium Phosphates, NDA 212832 | 216274 | American Regent, Inc. | Potassium Phosphates Injection USP, phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq/mL), phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials | 10/2/2023 | Yes | No | 10/16/2023 - Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL) Single-dose Vials; 10/13/2023 - Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials | |
243 | Xeljanz, NDA 213082 | 216878 | Slayback Pharma LLC | Tofacitinib Oral Solution, 1 mg/mL | 9/25/2023 | No | N/A | N/A | |
242 | AK-FLUOR, 10% and 25%, NDA 022186 | 215709 | Nexus Pharmaceuticals Inc. | Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials | 9/25/2023 | Yes | No | 10/24/2023 | |
241 | Ortho Evra, NDA 21180 | 214594 | Zydus Noveltech Inc. | Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day | 9/14/2023 | No | N/A | N/A | |
240 | Gadavist, NDA 201277 | 216081 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package | 9/8/2023 | Yes | No | 11/1/2023 | |
239 | Calcium Gluconate in Sodium Chloride, NDA 208418 | 217174 | Amneal Pharmaceuticals LLC | Calcium Gluconate in Sodium Chloride Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers | 9/5/2023 | Yes | No | 9/12/2023 | |
238 | Vyvanse, NDA 021977 |
215330 | Rhodes Pharmaceutical L.P. | Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg | 8/25/2023 | No | N/A | N/A | |
237 | Combigan, NDA 021398 |
215230 | Syneos Health, LLC | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% | 8/25/2023 | No | N/A | N/A | |
236 | Vyvanse, NDA 021977 |
214547 | Norwich Pharmaceuticals, Inc. | Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg | 8/25/2023 | No | N/A | N/A | |
235 | Dexamethasone, ANDA 088316 |
217695 | Apotex Corp. | Dexamethasone Tablets USP, 1 mg | 8/23/2023 | Yes | No | 11/1/2023 | |
234 | Zinc Sulfate, NDA 209377 |
217074 | Zydus Pharmaceuticals (USA) Inc. | Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL), and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package Vials | 8/22/2023 | No | N/A | N/A | |
233 | Retin-A-Micro, NDA 020475 |
215609 | Encube Ethicals Private Limited | Tretinoin Gel (Microsphere), 0.08% | 8/22/2023 | Yes | No | 9/8/2023 | |
232 | Calcium Gluconate in Sodium Chloride, NDA 208418 |
216541 | B. Braun Medical, Inc. | Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package | 8/21/2023 | Yes | No | 11/2/2023 | |
231 | Balcoltra, NDA 208612 |
214640 | Xiromed Pharma Espana, S.L. | Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg | 8/16/2023 | No | N/A | N/A | |
230 | Zonalon, NDA 020126 |
212357 | Amneal Pharmaceuticals, LLC | Doxepin Hydrochloride Cream, 5% | 8/16/2023 | No | N/A | N/A | |
229 | Thiola EC, NDA 211843 |
216278 | Amneal Pharmaceuticals of New York, LLC | Tiopronin Delayed-Release Tablets, 300 mg | 8/15/2023 | No | N/A | N/A | |
228 | Lithium Citrate, NDA 018421 |
218036 | Rubicon Research Private Limited | Lithium Oral Solution USP, 8 mEq/5 mL | 8/14/2023 | Yes | No | 9/20/2023 | |
227 | Potassium Chloride, ANDA 080205 | 217704 | Nexus Pharmaceuticals Inc. | Potassium Chloride for Injection Concentrate USP, 20 mEq/10 mL (2 mEq/mL) and 40 mEq/20 mL (2 mEq/mL) Single-Dose Vials | 8/14/2023 | Yes | No | 9/12/2023 | |
226 | Lexette, NDA 210566 |
215266 | Padagis US LLC | Halobetasol Propionate Topical Foam, 0.05% | 8/11/2023 | No | N/A | N/A | |
225 | Lotemax, NDA 202872 | 2215384 | Sun Pharmaceutical Industries, Inc. | Loteprednol Etabonate Ophthalmic Gel, 0.5% | 8/9/2023 | No | N/A | N/A | |
224 | Denavir, NDA 020629 | 216981 | Torrent Pharma Inc. | Penciclovir Cream, 1% | 8/7/2023 | Yes | No | 9/1/2023 | |
223 | Vancomycin, NDA 209481 |
217401 | Eugia US LLC | Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial (Single-Dose vials) | 8/4/2023 | No | N/A | N/A | |
222 | Indocin, NDA 017814 |
216184 | Zydus Worldwide DMCC | Indomethacin Suppositories USP, 50 mg | 8/2/2023 | Yes | No | 8/3/2023 | |
221 | Azopt, NDA 020816 | 211914 | Padagis USA LLC | Brinzolamide Ophthalmic Suspension USP, 1% | 7/28/2023 | Yes | No | 10/10/2023 | |
220 | Cardene, NDA 019488 | 215377 | Senores Pharmaceuticals, Inc. | Nicardipine Hydrochloride Capsules, 20 mg and 30 mg | 7/17/2023 | Yes | No | 9/19/2023 | |
219 | Sodium Phenylacetate and Sodium Benzoate, NDA 215025 | 217526 | Navinta LLC | Sodium Phenylacetate and Sodium Benzoate Injection, 10% / 10% (2g - 2 g/20 mL [0.1 g - 0.1 g/mL]) Single-Dose Vial | 7/14/2023 | Yes | No | 9/22/2023 | |
218 | Sodium Chloride 23.4%, NDA 019329 |
217796 | Fresenius Kabi USA, LLC | 23.4% Sodium Chloride Injection USP, 800 mEq/200 mL (4 mEq/mL) Pharmacy Bulk Package | 7/11/2023 | Yes | N/A | 7/27/2023 | |
217 | Sterile Water, NDA 018801 |
217536 | Nexus Pharmaceuticals Inc. | Sterile Water for Injection USP, 20 mL Single-Dose Vials | 7/11/2023 | Yes | Yes | N/A | |
216 | Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, NDA 050786 |
217511 | RinconPharma LLC | Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125mg/125 mg | 7/3/2023 | Yes | No | 7/3/2023 | |
215 | Vancomycin Hydrochloride, NDA 209481 |
217489 | Hikma Pharmaceuticals USA Inc. | Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial Single-Dose Vial | 6/29/2023 | Yes | No | 8/16/2023 | |
214 | Vancocin Hydrochloride, ANDA 061667 | 215338 | Amneal Pharmaceuticals LLC | Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL (50 mg/mL) | 6/23/2023 | Yes | No | 6/23/2023 | |
213 | Nasonex, NDA 215712 | 217460 | Amneal Pharmaceuticals LLC | Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC) |
6/14/2023 | Yes | Yes | N/A | |
212 | Katerzia, NDA 211340 | 215035 | Amneal Pharmaceuticals LLC | Amlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL) | 6/13/2023 | No | N/A | N/A | |
211 | Fleqsuvy, NDA 215602 | 217252 | Slayback Pharma LLC | Baclofen Oral Suspension, 25 mg/5 mL (5 mg/mL) | 6/8/2023 | No | N/A | N/A | |
210 | Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion, NDA 020068 | 213807 | Emcure Pharmaceuticals Ltd. | Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion | 6/5/2023 | No | N/A | N/A | |
209 | Arranon, NDA 021877 | 215057 | Nexus Pharmaceuticals Inc. | Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial | 6/2/2023 | No | N/A | N/A | |
208 | Fosamax, NDA 021575 | 214512 | Novitium Pharma LLC | Alendronate Sodium Oral Solution, 70 mg (base)/75 mL | 5/11/2023 | Yes | No | 5/24/2023 | |
207 | Dexamethasone, ANDA 081916 | 217696 | Novitium Pharma LLC | Dexamethasone Tablets USP, 2 mg | 5/9/2023 | No | N/A | N/A | |
206 | Calcium DisodiumVersenate, NDA 008922 | 216435 | Casper Pharma LLC | Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial | 5/2/2023 | Yes | No | 7/12/2023 | |
205 | Celontin, NDA 010596 | 217213 | Novitium Pharma LLC | Methsuximide Capsules USP, 300 mg | 5/1/2023 | Yes | No | 5/1/2023 | |
204 | Dexamethasone, ANDA 087916 | 217538 | Bionpharma Inc. | Dexamethasone Tablets USP, 2 mg | 4/26/2023 | No | N/A | N/A | |
203 | Tazorac, NDA 020600 | 213079 | Padagis Israel Pharmaceuticals Ltd. | Tazarotene Gel, 0.05% and 0.1% | 4/25/2023 | No | N/A | N/A | |
202 | Alrex, NDA 020803 | 215933 | Akorn Operating Company LLC | Loteprednol Etabonate Ophthalmic Suspension, 0.2% | 4/12/2023 | Yes | Yes | N/A | |
201 | Uceris, NDA 205613 | 215328 | Padagis Israel Pharmaceuticals Ltd. | Budesonide Rectal Foam, 2 mg/dose | 4/12/2023 | Yes | No | 4/27/2023 | |
200 | Paraflex, NDA 011300 | 214702 | Corepharma, LLC | Chlorzoxazone Tablets USP, 250 mg | 4/10/2023 | No | N/A | N/A | |
199 | Arranon, NDA 021877 | 216346 | Amneal Pharmaceuticals LLC | Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial | 4/4/2023 | No | N/A | N/A | |
198 | Alphagan P, NDA 021262 | 215225 | Syneos Health, LLC | Brimonidine Tartrate Ophthalmic Solution, 0.15% | 3/29/2023 | No | N/A | N/A | |
197 | Amitiza, NDA 021908 | 214131 | Zydus Pharmaceuticals (USA) Inc. | Lubiprostone Capsules, 8 mcg and 24 mcg | 3/23/2023 | No | N/A | N/A | |
196 | Enstilar, NDA 207589 | 214688 | Glenmark Pharmaceuticals Inc., USA | Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% | 3/21/2023 | No | N/A | N/A | |
195 | Tazorac, NDA 020600 | 213644 | Solaris Pharma Corporation | Tazarotene Gel, 0.05% and 0.1% | 3/20/2023 | No | N/A | N/A | |
194 | Prednisolone, ANDA 080354 | 215673 | Aurobindo Pharma Limited | Prednisolone Tablets USP, 5 mg | 3/17/2023 | Yes | No | 5/22/2023 | |
193 | Arranon, NDA 021877 | 214809 | Shorla Pharma Limited | Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial | 3/3/2023 | No | N/A | N/A | |
192 | Advil Dual Action with Acetaminophen, NDA 211733 | 214836 | L. Perrigo Company | Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) | 2/28/2023 | No | N/A | N/A | |
191 | Thiola EC, NDA 211843 | 217219 | Par Pharmaceutical Inc. | Tiopronin Delayed-Release Tablets, 100 mg and 300 mg | 2/24/2023 | No | N/A | N/A | |
190 | Zonalon, NDA 021026 | 215408 | Teva Pharmaceutical Development, Inc. | Doxepin Hydrochloride Cream, 5% | 2/17/2023 | Yes | No | 2/17/2023 | |
189 | Trokendi XR, NDA 201635 | 216167 | Zydus Pharmaceuticals (USA) Inc. | Topiramate Extended-Release Capsules, 200 mg | 2/9/2023 | No | N/A | N/A | |
188 | Parafon Forte DSC, NDA 011529 | 212047 | Appco Pharma LLC | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 1/27/2023 | No | N/A | N/A | |
187 | Phenylephrine Hydrochloride, NDA 207926 | 216496 | Mankind Pharma Limited | Phenylephrine Hydrochloride Ophthalmic Solution USP, 10% | 1/11/2023 | Yes | No | 1/18/2023 | |
186 | Arranon, NDA 021877 | 216038 | Meitheal Pharmaceuticals, Inc. | Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial | 1/10/2023 | No | N/A | N/A | |
185 | Orfadin, NDA 021232 | 215908 | Torrent Pharma Inc. | Nitisinone Capsules, 20 mg | 1/9/2023 | Yes | Yes | N/A | |
184 | Zinc Sulfate, NDA 209377 | 216145 | Fresenius Kabi USA, LLC | Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package | 12/27/2022 | Yes (10 mg/10 mL); No (30 mg/10 mL); No (25 mg/5 mL) | No | 2/15/2023 | |
183 | Cupric Sulfate, NDA 019350 | 216324 | American Regent, Inc. | Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL) Pharmacy Bulk Package | 12/26/2022 | Yes | Yes | N/A | |
182 | Uptravi, NDA 207947 | 214302 | Zydus Worldwide DMCC | Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg | 12/21/2022 | No | N/A | N/A | |
181 | Perforomist, NDA 22007 | 215621 | Slayback Pharma LLC | Formoterol Fumarate Solution 20 mcg/2 mL per Unit Dose Vial | 12/13/2022 | No | N/A | N/A | |
180 | Potassium Chloride, NDA 206814 | 211665 | Strides Pharma Global Pte Limited | Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) | 11/17/2022 | No | N/A | N/A | |
179 | AmBisome Liposome, NDA 050740 | 214010 | Eugia US LLC | Amphotericin B Injection, 50 mg/vial Single-Dose Vial | 11/17/2022 | No | N/A | N/A | |
178 | Durezol, NDA 022212 | 214894 | Dr. Reddy's Laboratories Limited | Difluprednate Ophthalmic Emulsion, 0.05% | 11/16/2022 | No | N/A | N/A | |
177 | Calcium Gluconate, NDA 208418 | 213071 | Nivagen Pharmaceuticals, Inc. | Calcium Gluconate Injection USP, 1,000 mg per 10 mL (100 mg per mL) Single-Dose Vial | 10/14/2022 | Yes | No | 11/6/2022 | |
176 | Briviact, NDA 205836 | 214501 | Zydus Pharmaceuticals (USA) Inc. | Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg | 10/3/2022 | No | N/A | N/A | |
175 | Phenylephrine Hydrochloride, NDA 207926 | 216859 | Mankind Pharma Limited | Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% w/v (2 mL fill) | 9/29/2022 | Yes | No | 10/7/2022 | |
174 | Pathocil, NDA 050011 | 216845 | Aurobindo Pharma USA, Inc. | Dicloxacillin Sodium Capsules USP, 250 mg and 500 mg | 9/23/2022 | Yes | No | 9/30/2022 | |
173 | Timoptic in Ocudose, NDA 019463 | 216533 | Ingenus Pharmaceuticals, LLC | Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials | 9/13/2022 | No | N/A | N/A | |
172 | Tazorac, NDA 020600 | 215433 | Cosette Pharmaceuticals, Inc. | Tazarotene Gel, 0.05% | 9/13/2022 | Yes | No | 9/14/2022 | |
171 | Tazorac, NDA 020600 | 214136 | Cosette Pharmaceuticals, Inc. | Tazarotene Gel, 0.01% | 9/13/2022 | Yes | No | 9/14/2022 | |
170 | Carafate, NDA 19183 | 212913 | Mylan Pharmaceuticals, Inc. | Sucralfate Oral Suspension, 1 g/10 mL | 9/12/2022 | No | N/A | N/A | |
169 | Dexamethasone, ANDA 087916 | 216295 | Amneal Pharmaceuticals LLC | Dexamethasone Tablets USP, 2 mg | 9/8/2022 | Yes | No | 9/9/2022 | |
168 | Lyrica CR, NDA 209501 | 215577 | Zydus Pharmaceuticals (USA) Inc. | Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, and 330 mg |
8/26/2022 | No | N/A | N/A | |
167 | Cetrotide, NDA 021197 | 215737 | Akorn Operating Company LLC | Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose | 8/12/2022 | Yes | No | 10/24/2022 | |
166 | Divigel, NDA 022038 | 211783 | Chemo Research S.L. | Estradiol Gel, 0.1% | 8/10/2022 | Yes | No | 10/10/2022 | |
165 | Clindagel, NDA 050782 | 214668 | Amneal Pharmaceuticals LLC | Clindamycin Phosphate Gel USP, 1% | 8/5/2022 | Yes | No | 8/5/2022 |
|
164 | Bactroban, NDA 050746 | 212465 | Padagis Israel Pharmaceuticals Ltd. | Mupirocin Cream USP, 2% |
8/3/2022 | No | N/A | N/A | |
163 | Taytulla, NDA 204426 | 213418 | Glenmark Pharmaceuticals Limited | Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg | 7/27/2022 | No | N/A | N/A | |
162 | Vasostrict, NDA 204485 | 211857 | Amphastar Pharmaceuticals, Inc. | Vasopressin Injection USP, 20 Units/mL Single-Dose Vials | 7/18/2022 | No | N/A | N/A | |
161 | Nalfon, NDA 017604 | 214475 | Rising Pharma Holdings, Inc. | Fenoprofen Calcium Capsules USP, 400 mg | 7/18/2022 | Yes | No | 8/15/2022 | |
160 | Atropine Sulfate, NDA 206289 | 214752 | Amneal Pharmaceuticals LLC | Atropine Sulfate Ophthalmic Solution USP, 1% | 7/14/2022 | No | N/A | N/A | |
159 | Isordil, NDA 012093 | 215723 | Rubicon Research Private Limited | Isosorbide Dinitrate Tablets USP, 40 mg | 7/8/2022 | No | N/A | N/A | |
158 | Neostigmine Methylsulfate, NDA 203629 | 216291 | Dr. Reddy's Laboratories Limited | Neostigmine Methylsulfate Injection USP, 3 mg/3 mL (1 mg/mL) Single-Dose Prefilled Syringes | 7/6/2022 | Yes | No | 7/25/2022 | |
157 | Plasma-Lyte 148 in Water, NDA 017378 | 215370 | Fresenius Kabi USA, LLC | Multiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers | 6/29/2022 | Yes | Yes | N/A | |
156 | Carbaglu, NDA 022562 | 213395 | Navinta LLC | Carglumic Acid Tablets for Oral Suspension, 200 mg | 6/22/2022 | No | N/A | N/A | |
155 | Narcan, NDA 208411 | 211951 | Padagis Israel Pharmaceuticals Ltd. | Naloxone Hydrochloride Nasal Spray, 4 mg/spray | 6/21/2022 | No | N/A | N/A | |
154 | Infants’ Advil, NDA 020812 | 214071 | Strides Pharma Inc. | Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) | 6/9/2022 | Yes | Yes | N/A | |
153 | Plasma-Lyte A, NDA 017378 | 215371 | Fresenius Kabi USA, LLC | Multiple Electrolytes Injection Type 1 USP, pH 7.4, Single-Dose Containers | 6/8/2022 | Yes | Yes | N/A | |
152 | Epiduo Forte, NDA 207917 | 214553 | Zydus Pharmaceuticals (USA) Inc. | Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% | 6/3/2022 | No | N/A | N/A | |
151 | Epiduo Forte, NDA 207917 | 212464 | Padagis US, LLC | Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% | 5/31/2022 | No | N/A | N/A | |
150 | Atropine Sulfate, NDA 214652 |
216120 | American Regent, Inc. | Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials | 5/26/2022 | Yes | No | 8/2/2022 |
|
149 | Brovana, NDA 021912 | 215385 | Sun Pharmaceutical Industries Ltd | Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vial | 5/26/2022 | No | N/A | N/A | |
148 | Alimta, NDA 021462 | 214073 | Zydus Pharmaceuticals (USA) Inc. | Pemetrexed for Injection USP, 1000 mg/vial |
5/25/2022 | No | N/A | N/A | |
147 | Lexiscan, NDA 022161 | 214252 | International Medication Systems, Limited | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe | 5/23/2022 | No | N/A | N/A | |
146 | Visipaque, NDA 20351 | 214271 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL Single Dose Bottles | 5/19/2022 | Yes | No | 7/13/2022 | |
145 | Pentasa, NDA 020049 | 214585 | Sun Pharmaceutical Industries Inc. | Mesalamine Extended Release Capsules USP, 500 mg | 5/11/2022 | Yes | No |
5/18/2022 |
|
144 | Brovana, NDA 021912 | 214779 | Alembic Pharmaceuticals Limited | Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial | 5/10/2022 | No | N/A | N/A | |
143 | Zinc Sulfate, NDA 209377 | 216249 | Gland Pharma Limited | Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) | 5/3/2022 |
Yes Yes |
No Yes |
6/27/2022 (30 mg/10 mL (3 mg/mL)) 25 mg/5 mL (5 mg/mL) |
|
142 | Targretin, NDA 021056 | 215398 | Amneal Pharmaceuticals LLC | Bexarotene Gel, 1% | 4/27/2022 | Yes | No | 5/17/2022 | |
141 | AquaMEPHYTON, NDA 012223 | 214596 | Cipla Limited | Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials | 4/22/2022 | Yes | No | 5/3/2022 | |
140 | AquaMEPHYTON, NDA 012223 | 212424 | Cipla Limited | Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules | 4/22/2022 | Yes | 5/3/2022 (by ANDA 214596) | ||
139 | Sinequan, NDA 016798 | 213796 | Edenbridge Pharmaceuticals, LLC | Doxepin Hydrochloride Capsules USP, 150 mg | 4/19/2022 | Yes | No | 5/2/2022 | |
138 | Mestinon, NDA 015193 | 212405 | Milla Pharmaceuticals, Inc | Pyridostigmine Bromide Solution USP, 60 mg/5 mL | 4/19/2022 | No | N/A | N/A | |
137 | Lexiscan, NDA 022161 | 213210 | Dr. Reddy's Laboratories, Inc. | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe | 4/11/2022 | No | N/A | N/A | |
136 | Ganirelix Acetate, NDA 021057 | 212613 | Amphastar Pharmaceuticals, Inc. | Ganirelix Acetate Injection, 250 mcg/0.5 mL Prefilled Syringe | 4/7/2022 | No | N/A | N/A | |
135 | Noxafil, NDA 205053 | 212500 | Dr. Reddy's Laboratories, Inc. | Posaconazole Delayed-Release Tablets, 100 mg | 4/7/2022 | No | N/A | N/A | |
134 | Butalbital and Acetaminophen, ANDA 89988 | 214088 | Havix Group Inc. | Butalbital and Acetaminophen Tablets, 25 mg/325 mg | 4/7/2022 | Yes | Yes | N/A | |
133 | BiDil, NDA 020727 | 215586 | RiconPharma LLC | Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg | 4/6/2022 | Yes | No | 4/12/2022 | |
132 | Revatio, NDA 203109 | 211638 | Lupin Pharmaceuticals, Inc. | Sildenafil for Oral Suspension, 10 mg/mL | 3/23/2022 | No | N/A | N/A | |
131 | Carafate, NDA 019183 | 211884 | VistaPharm, Inc. | Sucralfate Oral Suspension, 1 g/10 mL | 3/15/2022 | Yes | No | 3/15/2022 | |
130 | Brovana, NDA 021912 | 214736 | VistaPharm, Inc. | Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-Dose Vial | 3/2/2022 | No | N/A | N/A | |
129 | Apokyn, NDA 021264 | 212025 | Sage Chemical, Inc. | Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use Glass Cartridge | 2/23/2022 | Yes | No | 2/25/2022 | |
128 | Veltin, NDA 050803 | 212845 | Solaris Pharma Corporation | Clindamycin Phosphate and Tretinoin Gel, 1.2%/0.025% | 2/10/2022 | Yes | No | 4/12/2022 | |
127 | Lanoxin, NDA 020405 | 214982 | Aurobindo Pharma Limited | Digoxin Tablets USP, 0.0625 mg | 2/8/2022 | Yes | No | 2/17/2022 | |
126 | Revex, NDA 020459 | 212955 | Purdue Pharma L.P. | Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL) Single-Dose Vials | 2/8/2022 | Yes | Relinquished | N/A | |
125 | Cystadane, NDA 020576 | 210508 | Lukare Medical, LLC | Betaine Anhydrous for Oral Solution, 180 grams/bottle | 1/28/2022 | No | N/A | N/A | |
124 | Atropine Sulfate, NDA 021146 | 215342 | Amneal EU, Limited | Atropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) Single-Dose Syringe | 1/26/2022 | No | N/A | N/A | |
123 | Monurol, NDA 050717 | 211881 | Cipla USA, Inc. | Fosfomycin Tromethamine Suspension 3 g (base) Single-Dose Sachet | 1/26/2022 | No | N/A | N/A | |
122 |
Migranal, NDA 020148 |
214105 | Amneal Pharmaceuticals LLC | Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) | 1/4/2022 | No | N/A | N/A | |
121 | AmBisome Liposome, NDA 050740 | 212514 | Sun Pharmaceutical Industries Inc. | Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial | 12/14/2021 | Yes | No | 2/15/2022 | |
120 | Timoptic, NDA 019463 | 212592 | Pharmaceutical Project Solutions, Inc. | Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials | 12/13/2021 | Yes | No | 2/26/2022 | |
119 | Atropine Sulfate, NDA 209260 | 213561 | Hikma Pharmaceuticals USA Inc. |
Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multi-Dose Vial |
12/1/2021 | No | N/A | N/A | |
118 | Atropine Sulfate, NDA 206289 | 215624 | Apotex | Atropine Sulfate Ophthalmic Solution, USP 1% | 11/26/2021 | Yes | No | 11/26/2021 | |
117 | Cystadane, NDA 20576 | 214864 | Novitium Pharma | Betaine Anhydrous for Oral Solution, 180 grams/bottle | 11/23/2021 | Yes | No | 2/3/2022 | |
116 | Isordil, NDA 012093 | 211290 | Par Pharmaceutical, Inc. | Isosorbide Dinitrate Tablets USP, 40 mg | 11/23/2021 | Yes | No | 12/21/2021 | |
115 | Perforomist, NDA 022007 | 215078 | Alembic Pharmaceuticals Limited | Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial | 11/22/2021 | No | N/A | No | |
114 | Revatio, NDA 203109 | 212312 | Tris Pharma, Inc. | Sildenafil for Oral Suspension, 10 mg/mL | 11/17/2021 | No | N/A | No | |
113 | Arranon, NDA 021877 | 215037 | Zydus Pharmaceuticals (USA) Inc. | Nelarabine Injection, 250 mg/50 mL (5 mg/mL), SingleDose Vial | 11/17/2021 | Yes | No | 11/23/2021 | |
112 | Bactroban, NDA 050746 | 213053 | Aleor Dermaceuticals Limited | Mupirocin Cream USP, 2% | 11/16/2021 | Yes | No | 12/29/2021 | |
111 | Librax, NDA 012750 | 211476 | Teva Pharmaceuticals USA, Inc. | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 11/2/2021 | No | N/A | N/A | |
110 | Prexxartan, NDA 209139 | 214102 | Novitium Pharma, LLC | Valsartan Oral Solution, 20 mg/5 mL (4 mg/mL) | 11/2/2021 | Yes | Yes | N/A | |
109 | Monurol, NDA 050171 | 214554 | Alkem Laboratories Limited | Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet | 10/21/2021 | No | N/A | ||
108 | Decadron, NDA 011664 | 215106 | Amneal EU, Limited | Dexamethasone Tablets USP, 4 mg and 6 mg | 10/14/2021 | Yes | No | 4 mg - 10/22/2021; 6 mg - 10/21/2021 | |
107 | Carbaglu, NDA 016636 | 213729 | Novitium Pharma, LLC | Carglumic Acid Tablets for Oral Suspension, 200 mg | 10/13/2021 | Yes | N0 | 12/20/2021 | |
106 | Mexitil, NDA 018873 | 214089 | Aavis Pharmaceuticals | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg | 10/1/2021 | No | N/A | N/A | |
105 | Zomig, NDA 021450 | 212469 | Padagis US, LLC | Zolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray | 9/30/2021 | No | N/A | N/A | |
104 | Absorica, NDA 021951 | 212333 | Upsher-Smith Laboratories, LLC | Isotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg | 9/21/2021 | No | N/A | N/A | |
103 | Quinaglute, NDA 016647 | 212589 | Eywa Pharma, Inc. | Quinidine Gluconate Extended-Release Tablets USP, 324 mg | 9/17/2021 | Yes | Yes | N/A | |
102 | Paxil, NDA 020710 | 215003 | Novitium Pharma LLC | Paroxetine Oral Suspension, 10 mg (base)/5 mL | 9/3/2021 | Yes | No | 9/13/2021 | |
101 | Ortho Evra, NDA 021180 | 213977 | Teva Pharmaceuticals USA, Inc. | Onsura (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day |
8/25/2021 | No | N/A | N/A | |
100 | Aramine, NDA 009509 | 211304 | Slayback Pharma LLC | Metaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial | 8/24/2021 | Yes | Yes | N/A | |
99 | Cuprimine, NDA 019853 | 213293 | InvaGen Pharmaceuticals, Inc. | Penicillamine Capsules USP, 250 mg | 8/19/2021 | No | N/A | N/A | |
98 | Clindagel, NDA 050782 | 212842 | Solaris Pharma Corporation | Clindamycin Phosphate Gel USP, 1% | 8/13/2021 | No | N/A | N/A | |
97 | Loperamide Hydrochloride, NDA 21855 | 213070 | Strides Pharma, Inc. | Loperamide Hydrochloride Capsules USP, 2 mg (OTC) | 8/11/2021 | Yes | No | 10/22/2021 | |
96 | Paraflex, NDA 011300 | 215158 | Havix Group, Inc. | Chlorzoxazone Tablets USP, 250 mg | 7/29/2021 | Yes | No | 9/30/2021 | |
95 | Daraprim, NDA 008578 | 211271 | Alvogen | Pyrimethamine Tablets USP, 25 mg | 7/27/2021 | Yes | No | 10/4/2021 | |
94 | Ery-Tabs, ANDA 062298 | 211975 | Torrent Pharma Inc. | Erythromycin Delayed-Release Tablets USP, 250 mg and 500 mg | 7/26/2021 | Yes | No | 10/4/2021 | |
93 | Atropine Sulfate, NDA 021146 | 212868 | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe | 7/26/2021 | Yes | No | 7/30/2021 | |
92 | Taytulla, NDA 204426 | 214292 | Amneal Pharmaceuticals | Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg | 7/20/2021 | No | N/A | N/A | |
91 | Theophylline, ANDA 90430 | 212184 | Glenmark Pharmaceuticals Limited | Theophylline Extended-Release Tablets, 450 mg | 6/3/2021 | Yes | No | 6/11/2021 | |
90 | Thorazine, NDA 009149 | 214542 | Genus Lifesciences Inc. | Chlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL | 6/2/2021 | Yes | No | 8/2/2021 | |
89 | Miacalcin Injection, NDA 017808 | 212416 | Custopharm, Inc. | Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial | 5/14/2021 | Yes | No | 5/14/2021 | |
88 | Revatio, NDA 203109 | 213014 | Hetero Labs Limited | Sildenafil for Oral Suspension, 10 mg/mL | 5/11/2021 | No | N/A | N/A | |
87 | Librax, NDA 012750 | 214698 | Dr. Reddy's Laboratories Limited | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 5/10/2021 | No | N/A | N/A | |
86 | Sodium Acetate, NDA 018893 | 214805 | Milla Pharmaceuticals, Inc. | Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials | 5/4/2021 | Yes | No | 7/7/2021 | |
85 | Thiola, NDA 019569 | 214326 | Teva Pharmaceuticals USA, Inc. | Tiopronin Tablets, 100 mg | 4/26/2021 | No | N/A | N/A | |
84 | Librax, NDA 012750 | 214065 | Alkem Laboratories Limited | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 4/26/2021 | No | N/A | N/A | |
83 | Bentyl, NDA 007961 | 214721 | Novitium Pharma LLC | Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL | 4/23/2021 | No | N/A | N/A | |
82 | Foscavir, NDA 020068 | 213001 | Gland Pharma Limited | Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) | 4/21/2021 | Yes | No | 7/1/2021 | |
81 | Thorazine, NDA 009149 | 212144 | Glenmark Pharmaceuticals Limited | Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg | 3/23/2021 | Yes | No | 3/24/2021 | |
80 | Cardizem SR, NDA 019471 | 212317 | Glenmark Pharmaceuticals Limited | Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg | 3/22/2021 | Yes | No | 3/30/2021 | |
79 | Atropine Sulfate, NDA 209260 | 213424 | Accord Healthcare Inc. | Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial | 3/19/2021 | Yes | No | 3/25/2021 | |
78 | Lotemax, NDA 020583 | 212450 | Sun Pharmaceutical Industries Inc. | Loteprednol Etabonate Ophthalmic Suspension, 0.5% | 2/26/2021 | Yes | No | 5/6/2021 | |
77 | Ortho Evra, NDA 021180 | 213950 | Amneal | Norelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day | 2/25/2021 | Yes | No | 2/26/2021 | |
76 | Northera NDA 203202 | 211818 | Zydus Pharmaceuticals (USA) Inc. | Droxidopa Capsules, 100 mg, 200 mg, 300 mg | 2/18/2021 | No | N/A | N/A | |
75 | Lotemax, NDA 202872 | 212080 | Akorn Operating Company LLC | Loteprednol Etabonate Ophthalmic Gel, 0.5% | 2/10/2021 | No | N/A | N/A | |
74 | Jadenu, NDA 207968 | 214194 | Amneal | Deferasirox Oral Granules, 180 mg and 360 mg | 2/9/2021 | No | N/A | N/A | |
73 | Kenalog, NDA 011600 | 212460 | Perrigo Israel Pharmaceuticals Ltd. | Triamcinolone Acetonide Ointment USP, 0.05% | 2/5/2021 | No | N/A | N/A | |
72 | Sabril, NDA 020427 | 211539 | Dr. Reddy's Laboratories Limited | Vigabatrin Tablets USP, 500 mg | 1/29/2021 | Yes | No | 2/1/2021 | |
71 | Eveko, NDA 209905 | 212186 | Glemark Pharmaceuticals Limited | Amphetamine Sulfate Tablets USP, 5 mg and 10 mg | 1/27/2021 | No | N/A | N/A | |
70 | Mexitil, NDA 018873 | 214352 | RiconPharma LLC | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg | 1/25/2021 | No | N/A | N/A | |
69 | Argatroban, NDA 203049 | 214235 | Caplin Steriles Limited | Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial | 1/21/2021 | Yes | Yes | N/A | |
68 | Narcan, NDA 016636 | 213279 | Aurobindo Pharma Limited | Naloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes | 1/14/2021 | No | N/A | N/A | |
67 | Taytulla, NDA 204426 | 212706 | Slayback Pharma LLC | Merzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg) | 12/18/2020 | Yes | No | 1/18/2021 | |
66 | Jublia, NDA 203567 | 211827 | Teva Pharmaceuticals USA, Inc. |
|
12/16/2020 | No | N/A | N/A | |
65 | Jublia, NDA 203567 | 211851 | Perrigo Pharma International DAC | Efinaconazole Topical Solution, 10% | 12/16/2020 | NO | N/A | N/A | |
64 | Amicar, NDA 015197 | 211629 | ANI Pharmaceuticals, Inc. | Aminocaproic Acid Tablets USP, 500 mg | 12/14/2020 | No | N/A | N/A | |
63 | Morphine Sulfate, NDA 022207 | 212451 | Alkem Laboratories | Morphine Sulfate Tablets, 15 mg and 30 mg | 12/3/2020 | Yes | No | 2/11/2021 | |
62 | Depen, NDA 019854 | 212933 | Lupin Limited | Penicillamine Tablets USP, 250 mg | 11/30/2020 | No | N/A | N/A | |
61 | Alinia, NDA 021497 | 213820 | Rising Pharma Holding, Inc. | Nitazoxanide Tablets, 500 mg | 11/27/2020 | Yes | No | 12/7/2020 | |
60 | Kenalog, NDA 011600 | 213619 | Cintex Services, LLC | Triamcinolone Acetonide Ointment USP, 0.05% | 11/10/2020 | No | N/A | N/A | |
59 | Parafon Forte DSC, NDA 011529 | 212743 | Par Pharmaceutical, Inc. | Chlorzoxazone Tablets USP, 750 mg | 11/2/2020 | No | N/A | N/A | |
58 | Timoptic-XE, NDA 020330 | 212942 | Alembic Pharmaceuticals Limited | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% | 10/22/2020 | Yes | No | 11/25/2020 | |
57 | Librax, NDA 012750 | 213530 | ECI Pharmaceuticals, LLC | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg | 10/20/2020 | Yes | No | 10/26/2020 | |
56 | Kerydin, NDA 204427 | 211848 | Perrigo Pharma International DAC | Tavaborole Topical Solution, 5% | 10/13/2020 | No | N/A | N/A | |
55 | Monurol, NDA 050717 | 212548 | Xiromed Pharma Espana, S.L. | Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet | 10/6/2020 | Yes | No | 10/6/2020 | |
54 | Firazyr, NDA 022150 | 213054 | Dr. Reddy's Laboratories Limited | Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe | 10/5/2020 | No | N/A | N/A | |
53 | Claritin RediTabs, NDA 021993 | 212795 | Tenshi Kaizen Private Limited. | Loratadine Orally Disintegrating Tablets USP, 5 mg | 9/18/2020 | Yes | Yes | N/A | |
52 | Parafon Forte DSC, NDA 011529 | 212053 | i3 Pharmaceuticals | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 9/14/2020 | No | N/A | N/A | |
51 | Taclonex, NDA 22185 | 212367 | Perrigo | Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% | 9/11/2020 | No | N/A | N/A | |
50 | Nascobal, NDA 21642 | 212458 | Perrigo | Cyanocobalamin Nasal Solution 500 mcg/spray | 9/9/2020 | No | N/A | N/A | |
49 | Daptomycin, NDA 208385 | 211403 | Dr. Reddy's Laboratories Inc. | Daptomycin for Injection, 350 mg per vial (single-dose vial) |
8/31/2020 | No | N/A | N/A | |
48 | Revatio, NDA 203109 | 213041 | AptaPharma, Inc. | Sildenafil for Oral Suspension, 10mg/mL | 8/6/2020 | No | N/A | N/A | |
47 | Cuprimine, NDA 019853 | 211867 | Dr Reddy's Laboratories, Inc. | Penicillamine Capsules USP, 250 mg | 8/4/2020 | No | N/A | N/A | |
46 | Metro I.V., NDA 018900 | 212435 | Gland Pharma Limited | Metronidazole Injection USP, 500 mg/100 mL (5 mg/mL) | 8/3/2020 | Yes | Yes | N/A | |
45 | Demser, NDA 017871 | 213734 | Amneal | Metyrosine Capsules USP, 250 mg | 7/24/2020 | Yes | No | 7/30/2020 | |
44 | Mexitil, NDA 018873 | 213500 | CrossMedika SA | Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg | 7/22/2020 | Yes | No | 7/22/2020 | |
43 | Parafon Forte DSC, NDA 011529 | 212898 | Teva Pharmaceuticals USA, Inc. | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 6/17/2020 | No | N/A | N/A | |
42 | Albenza, NDA 020666 | 211636 | Lupin Limited | Albendazole Tablets USP, 200 mg | 6/10/2020 | Yes | Yes | N/A | |
41 | Kenalog, NDA 011600 | 212356 | Strides Pharma Inc. | Triamcinolone Acetonide Ointment USP, 0.05% | 6/1/2020 | No | N/A | N/A | |
40 | Revatio, NDA 203109 | 211534 | Teva Pharmaceuticals USA, Inc. | Sildenafil for Oral Suspension, 10 mg/mL | 5/29/2020 | No | N/A | N/A | |
39 | Parafon Forte DSC, NDA 011529 | 212185 | Glenmark Pharmaceuticals Limited | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 5/26/2020 | No | N/A | N/A | |
38 | Bentyl, NDA 007961 | 212286 | Hikma Pharmaceuticals USA Inc. | Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL | 5/22/2020 | Yes | No | 5/22/2020 | |
37 | Migranal, NDA 020148 | 212907 | Cipla Limited | Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) | 5/20/2020 | Yes | No | 5/23/2020 | |
36 | K-Dur, NDA 019439 |
212861 | Amneal | Potassium Chloride Extended-Release Tablets USP, 15 mEq | 5/8/2020 | Yes | Yes | N/A | |
35 | Butrans, NDA 021306 |
211586 | Amneal | Buprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour | 4/14/2020 | Yes (7.5 mcg/hour); No (20 mcg/hour); No (15 mcg/hour); No (10 mcg/hour); No (5 mcg/hour) |
No | 4/16/2020 | |
34 | Adrenalin, NDA 204640 | 211880 | International Medication Systems, Limited | Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) | 4/24/2020 | No | N/A | N/A | |
33 | Narcan, NDA 16636 |
213209 | Dr. Reddy's Laboratories Limited | Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) | 3/16/2020 | Yes | No | 3/18/2020 | |
32 | Tepadina, NDA 208264 | 213049 | MSN Pharmaceuticals Inc. | Thiotepa for Injection USP, 15mg/vial and 100 mg/vial | 3/4/2020 | No | N/A | N/A | |
31 | Depen, NDA 19854 | 211497 | Teva Pharmaceuticals USA, Inc. | Penicillamine Tablets USP, 250mg | 2/13/2020 | Yes | Yes | N/A | |
30 | Mestinon, NDA 15193 | 212702 | Amneal | Pyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL | 1/10/2020 | No | N/A | N/A | |
29 | Valium, NDA 016087 | 211998 | Beloteca, Inc. | Diazepam Injection USP, 50 mg/10 mL (5 mg/mL) | 12/26/2019 | Yes | Yes | N/A | |
28 | Proglycem, NDA 017453 | 211050 | e5 Pharma, LLC | Diazoxide Oral Suspension USP, 50 mg/mL, | 12/20/2019 | Yes | No | 12/20/2019 | |
27 | Triamcinolone Acetonide, ANDA 089595 | 212384 | Encube | Triamcinolone Acetonide Ointment USP, 0.05% | 11/29/2019 | Yes | No | 12/2/2019 | |
26 | Amicar, NDA 15197 | 212492 | Amneal | Aminocaproic Acid Tablets USP, 500 mg | 11/27/2019 | Yes | No | 12/3/2019 | |
25 | Chlorzoxazone, ANDA 40861 | 212253 | Novitium Pharma | Chlorzoxazone Tablets USP, 375 mg and 750 mg | 11/27/2019 | Yes | No | 11/27/2019 | |
24 | Revatio, NDA 203109 | 212440 | Alkem Laboratories | Sildenafil for Oral Suspension, 10 mg/mL | 11/27/2019 | No | N/A | N/A | |
23 | Revatio, NDA 203109 | 212883 | Ajanta Pharma | Sildenafil for Oral Suspension, 10 mg/mL | 11/27/2019 | No | N/A | N/A | |
22 | Butalbital and Acetaminophen, ANDA 207313 | 213115 | Granules | Butalbital and Acetaminophen Capsules, 50 mg/300 mg | 11/25/2019 | Yes | No | 1/30/2020 | |
21 | Eryped, NDA 050207 | 211991 | Par Pharmaceutical Inc. | Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL | 10/23/2019 | Yes | Yes (400 mg) | 11/11/2019 (200 mg) | |
20 | Rapamune, NDA 21083 | 211406 | Apotex | Sirolimus Oral Solution, 1 mg/mL | 10/22/2019 | No | N/A | N/A | |
19 | Digoxin, NDA 21648 | 213000 | Novitium Pharma | Digoxin Oral Solution USP, 0.05 mg/mL | 10/4/2019 | Yes | No | 10/4/2019 | |
18 | Elidel, NDA 21302 | 211769 | Glenmark | Pimecrolimus Cream, 1% | 8/29/2019 | No | N/A | N/A | |
17 | Orfadin, NDA 21232 | 211041 | Novitium Pharma | Nitisinone Capsules, 2 mg, 5 mg and 10 mg | 8/26/2019 | No | N/A | N/A | |
16 | Amicar, NDA 15230 | 212780 | Amneal | Aminocaproic Acid Oral Solution USP, 0.25 g/mL | 8/23/2019 | Yes | No | 8/30/2019 | |
15 | Aleve PM, NDA 205352 | 211830 | Apotex | Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg | 8/22/2019 | Yes | Yes | N/A | |
14 | Levocarnitine, NDA 19257 | 211676 | Novitium Pharma | Levocarnitine Sugar Free Oral Solution, 1 g/mL | 8/14/2019 | Yes | No | 10/16/2019 | |
13 | Daptomycin, NDA 208385 | 212667 | Accord | Daptomycin for Injection, 350 mg/vial | 7/12/2019 | Yes | No | 7/16/2019 | |
12 | Hemabate, NDA 17989 | 211941 | Dr. Reddy's Laboratories | Carboprost Tromethamine Injection, 250 mcg/mL | 7/2/2019 | Yes | No | 7/2/2019 | |
11 | Cuprimine, NDA 19853 | 210976 | Watson | Penicillamine Capsule, 250 mg | 6/24/2019 | Yes | No | 6/25/2019 | |
10 | Revatio, NDA 203109 | 212260 | Novitium Pharma | Sildenafil Citrate for Oral Suspension, 10 mg/mL | 5/31/2019 | Yes | No | 5/31/2019 | |
9 | Navane, NDA 16584 | 211642 | Novitium Pharma | Thiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg | 4/5/2019 | Yes | No | 4/5/2019 | |
8 | Methergine, NDA 06035 | 211455 | Teva | Methylergonovine Maleate Tablets, 0.2 mg | 3/20/2019 | No | N/A | N/A | |
7 | Mestinon, NDA 15193 | 211694 | Novitium Pharma | Pyridostigmine Bromide Oral Syrup, 60 mg/5 mL | 3/8/2019 | Yes | No | 3/8/2019 | |
6 | Rapamune, NDA 21083 | 211040 | Novitium Pharma | Sirolimus Solution, 1 mg/mL | 1/28/2019 | No | N/A | N/A | |
5 | Westcort, NDA 01872 | 211750 | Glenmark | Hydrocortisone Valerate Ointment, 0.2 % | 12/14/2018 | Yes | No | 1/17/2019 | |
4 | Levo-Dromoran, NDA 08720 | 211484 | Virtus | Levorphanol Tartrate Tablet, 2 mg | 12/13/2018 | Yes | No | 12/13/2018 | |
3 | Amphetamine, ANDA 200166 | 211139 | Amneal | Amphetamine Sulfate Tablet, 5 mg and 10 mg | 9/26/2018 | Yes | No | 9/27/2018 (5 mg) 10/1/2018 (10 mg) |
|
2 | Methergine, NDA 06035 | 211483 | Amneal | Methylergonovine Maleate Tablets, 0.2 mg | 9/10/2018 | Yes | No | 9/21/2018 | |
1 | Potassium Chloride, NDA 206814 | 211067 | Apotex | Potassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL | 8/8/2018 | Yes | No | 8/29/2018 (20 mg) 9/7/2018 (40 mg) |