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
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.
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.” In certain cases when we did not make a determination regarding eligibility for CGT exclusivity at the time of approval this column will indicate “Deferred.” This would occur when the application is for a CGT that is approved on the first day on which any application for such CGT is approved, and is not eligible for 180-day patent challenge exclusivity, but when FDA has not determined whether all drug versions have forfeited eligibility for 180-day patent challenge exclusivity as described in section 505(j)(5)(B)(v)(III)(bb)(CC) of the FD&C Act. If FDA deferred the determination of whether the paragraph IV first applicant(s) for a drug forfeited eligibility for exclusivity in the patent challenge exclusivity context, we will generally also defer this determination in the 180-day CGT exclusivity context unless it is necessary to determine in the context of specific ANDAs otherwise ready for approval.
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.

CGT Approvals List

No.	RLD & NDA No.	ANDA No.	ANDA Applicant	Active Ingredient, Form, Strength	Approval Date	CGT Eligible	CGT Forfeiture	First Marketing Date
359	Motegrity, NDA 210166	218492	Novitium Pharma LLC	Prucalopride Tablets, 1 mg and 2 mg	12/26/2024	Yes	No	12/26/2024
358	Tetracaine Hydrochloride, NDA 210821	217227	Somerset Therapeutics LLC	Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%	12/20/2024	Yes
357	ProvayBlue, NDA 204630	216959	RK Pharma Inc.	Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL)	12/17/2024	No	N/A	N/A
356	Rectiv, NDA 021359	216452	Encube Ethicals Private Limited	Nitroglycerin Ointment USP, 0.4%	12/16/2024	No	N/A	N/A
355	Alrex, NDA 020803	216345	Amneal EU, Limited	Loteprednol Etabonate Ophthalmic Suspension, 0.2%	12/13/2024	No	N/A	N/A
354	Miacalcin, NDA 017808	212675	Fresenius Kabi USA, LLC	Calcitonin Salmon Injection USP, 400 I.U. per 2 mL (200 I.U. per mL) Multi-Dose Vial	12/5/2024	No	N/A	N/A
353	Abilify, NDA 202971	216608	Mylan Pharmaceuticals, Inc.	Aripiprazole for Extended-Release Injectable Suspension, 300 mg/vial and 400 mg/vial, Single-Dose Vial	12/3/2024	No	N/A	N/A
352	Atropine Sulfate, NDA 209260	215005	Somerset Therapeutics LLC	Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multiple-Dose Vials	11/29/2024	No	N/A	N/A
351	Rectiv, NDA 021359	212222	Acrux DDS Pty Ltd	Nitroglycerin Ointment USP, 0.4%	11/29/2024	No	N/A	N/A
350	Provayblue, NDA 204630	216955	Steriscience Pte. Limited	Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Ampule	11/22/2024	No	N/A	N/A
349	Provayblue, NDA 204630	217561	Nexus Pharmaceuticals LLC	Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Vial	11/21/2024	No	N/A	N/A
348	Indocin, NDA 017814	215899	Hikma Pharmaceuticals USA, Inc.	Indomethacin Suppositories USP, 50 mg	11/19/2024	No	N/A	N/A
347	Chromic Chloride in Plastic Container, NDA 018961	218538	Stira Pharmaceuticals LLC	Chromic Chloride Injection USP, 40 mcg/10 mL (4 mcg/mL) Single-Dose Vials	11/18/2024	Yes
346	Clomid, NDA 016131	216545	Rubicon Research Private Limited	Clomiphene Citrate Tablets USP, 50 mg	11/12/2024	No	N/A	N/A
345	Clomid, NDA 016131	216739	Appco Pharma LLC	Clomiphene Citrate Tablets USP, 50 mg	11/8/2024	Yes	No	11/19/2024
344	Cetraxal, NDA 021918	217887	IdentiRx, LLC	Ciprofloxacin Otic Solution, 0.2% (Single-Dose Vial)	11/5/2024	Yes	No	12/13/2024
343	Emflaza, NDA 208684	216720	Upsher-Smith Laboratories, LLC	Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg	11/5/2024	No	N/A	N/A
342	Radicava, NDA 209176	217565	XGen Pharmaceuticals DJB Inc.	Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Vials	10/31/2024	No	N/A	N/A
341	Eprontia, NDA 214679	217795	Alkem Laboratories Limited	Topiramate Oral Solution, 25 mg/mL	10/31/2024	No	N/A	N/A
340	Nicardipine Hydrochloride, NDA 022276	215406	Amneal EU, Limited	Nicardipine Hydrochloride Injection USP, 25 mg/10 mL (2.5 mg/mL) Single-Dose Vial	10/31/2024	Yes		No
339	Cyclophosphamide, NDA 212501	216783	Nexus Pharmaceuticals LLC	Cyclophosphamide Injection, 500 mg/2.5 mL (200 mg/mL) and 1 gram/5 mL (200 mg/mL) per Multiple-Dose Vials	10/29/2024	No	N/A	N/A
338	Estrogel, NDA 021166	217882	Novitium Pharma LLC	Estradiol Gel, 0.06%	10/23/2024	No	N/A	N/A
337	Zinc Chloride, NDA 018959	216152	Somerset Therapeutics LLC	Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials	10/16/2024	Yes	No	10/16/2024
336	Akovaz, NDA 208289	217721	Hikma Pharmaceuticals USA, Inc.	Ephedrine Sulfate Injection USP, 25 mg/5 mL (5 mg/mL) Single-Dose Prefilled Syringes	10/11/2024	Yes	No	12/20/2024
335	Brevital Sodium, NDA 011559	215488	Steriscience Pte. Limited	Methohexital Sodium for Injection USP, 500 mg/vial	10/3/2024	Yes	No	12/12/2024
334	Chantix, NDA 021928	215931	Dr. Reddy's Laboratories Limited	Varenicline Tablets, 0.5 mg and 1 mg	10/1/2024	No	N/A	N/A
333	Keflet, NDA 050440	218947	Alkem Laboratories Limited	Cephalexin Tablets USP, 250 mg and 500 mg	9/27/2024	Yes	No	10/11/2024 (by ANDA 218817)
332	Keflet, NDA 050440	218817	Aurobindo Pharma Limited	Cephalexin Tablets USP, 250 mg and 500 mg	9/27/2024	Yes	No	10/11/2024
331	Denavir, NDA 020629	212368	Padagis Israel Pharmaceuticals LTD	Penciclovir Cream, 1%	9/27/2024	No	N/A	N/A
330	Dexmedetomidine, NDA 206628	218112	Somerset Therapeutics LLC	Dexmedetomidine Injection USP, 400 mcg/4 mL (100 mcg/mL) and 1000 mcg/10 mL (100 mcg/mL) Multi-dose Vials	9/24/2024	Yes	No	10/1/2024
329	Nicardipine in Sodium Chloride, NDA 22276	215592	Cipla Limited	Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Containers	9/24/2024	Yes	No	11/22/2024
328	Miacalcin, NDA 017808	213766	Cipla Limited	Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial	9/20/2024	No	N/A	N/A
327	Nubain, NDA 18024	216049	Somerset Therapeutics LLC	Nalbuphine Hydrochloride Injection, 100 mg/10mL (10 mg/mL) and 200 mg/10 mL (20 mg/mL) Multiple-dose Vials	9/19/2024	Yes	No	10/1/2024
326	Nubain, NDA 18024	216050	Somerset Therapeutics LLC	Nalbuphine Hydrochloride Injection, 10 mg/mL and 20 mg/mL Single-dose Ampules	9/19/2024	Yes	No	9/25/2024
325	Theo-Dur, NDA 85328	215312	Strides Pharma Global Pte Limited	Theophylline Extended-Release Tablets, 300 mg and 450 mg	9/5/2024	Yes - 300 mg No - 450 mg	No	9/27/2024
324	Solu-Cortef, NDA 09866	214050	Cipla Limited	Hydrocortisone Sodium Succinate Injection USP, 100 mg/vial, Single-Dose Vial	9/5/2024	Yes	No	9/26/2024
323	Gocovri, NDA 208944	214897	Zydus Worldwide DMCC	Amantidine Extended-release Capsules, 68.5 mg	8/26/2024	No	N/A	N/A
322	Advil Dual Action with Acetaminophen, NDA 211733	218247	Dr. Reddy's Laboratories Limited	Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)	8/23/2024	No	N/A	N/A
321	Asacol HD, NDA 21830	213191	Teva Pharmaceuticals Inc.	Mesalamine Delayed-release Tablets USP, 800 mg	8/22/2024	Yes	No	8/22/2024
320	Lucemyra, NDA 209229	218613	Indoco Remedies Limited	Lofexidine Tablets, 0.18 mg	8/20/2024	Yes	No	8/28/2024
319	ERY-TAB ANDA 062298	211975	Torrent Pharma Inc.	Erythromycin Delayed-Release Tablets USP, 333 mg	8/13/2024	Yes	No	10/24/2024
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	No	10/11/2024
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	No	9/9/2024
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, NDA 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		6/24/2024 (by ANDA 216113)
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	No	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	216899	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	MeithealPharmaceuticals, 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, NDA017378	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, NDA012750	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, NDA021180	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
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)