ANDA Approvals Fall 2021 | Hatch-Waxman | Robins Kaplan LLP Law Firm

New Drug Applications and 505(b)(2) Applications

Third Quarter

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
7/01/2021	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Zydus Pharms
7/01/2021	Docetaxel	Docetaxel	Hospira	Gland Pharma
7/01/2021	Mucinex DM	Guaifenesin / Dextromethorphan Hydrobromide	Indivior	Sun
7/02/2021	Lyrica CR	Pregabalin	Pfizer	Mylan
7/02/2021	Cedazuridine	Decitabine	Otsuka	Meitheal
7/06/2021	Invega Sustenna	Paliperidone Palmitate	Johnson & Johnson	Teva
7/06/2021	Lyrica CR	Pregabalin	Pfizer	Alvogen
7/06/2021	Robinul	Glycopyrrolate	AH Robins	Meitheal
7/06/2021	Deltasone	Prednisone	Pharmacia / Upjohn	Novitium Pharma
7/7/2021	Norpramin	Desipramine HCl	Validus	Alembic
7/7/2021	Lyrica	Pregabalin	Upjohn	Apotex
7/8/2021	Tarceva	Erlotinib HCl	OSI Pharma	Alembi
7/9/2021	Brilinta	Ticagrelor	AstraZeneca	Mylan
7/9/2021	Trileptal	Oxcarbazepine	Novartis	Akorn
7/9/2021	Mycamine	Micafungin Sodium	Astellas	Hikma
7/9/2021	Mycamine	Micafungin Sodium	Astellas	Jiangsu Hansoh Pharm
7/12/2021	Promethazine Hydrochloride Plain	Promethazine HCl	ANI Pharma	Quagen
7/12/2021	Nitropress	Sodium Nitroprusside	AbbVie	Be Pharms
7/13/2021	Imitrex	Sumatriptan Succinate	Glaxo	Caplin
7/13/2021	Lioresal	Baclofen	Novartis	Aurobindo
7/14/2021	Lipitor	Atorvastatin Calcium	Upjohn	Dr Reddys Labs
7/15/2021	Arthrotec	Diclofenac Sodium / Misoprostol	Pfizer	Micro Labs
7/15/2021	Estrace	Estradiol	AbbVie	Prasco Labs
7/15/2021	Tobradex	Tobramycin / Dexamethasone	Novartis	Amneal
7/15/2021	Apriso	Mesalamine	Bausch & Lomb	Alkem
7/15/2021	Lyrica	Pregabalin	Upjohn	Changzhou Pharm
7/16/2021	Samsca	Tolvaptan	Otuska	Hetero Labs
7/16/2021	Lioresal	Baclofen	Novartis	Beximco Pharms
7/19/2021	Adalat CC	Nifedipine	Alvogen	Aurobindo
7/20/2021	Vimovo	Naproxen / Esomeprazole Magnesium	Horizon	Mylan
7/20/2021	Taytulla	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	AbbVie	Amneal
7/26/2021	Eliquis	Apixaban	Bristol-Myers Squibb	Breckenridge
7/26/2021	Ery-Tab	Erythromycin	Arbor	Torrent
7/26/2021	Atropine Sulfate	Atropine Sulfate	Hospira	Accord Healthcare
7/26/2021	Haldol	Haloperidol Decanoate	Janssen	Meitheal
7/27/2021	Daraprim	Pyrimethamine	Vyera	Alvogen / Fera
7/27/2021	Emla	Lidocaine / Prilocaine	Teva	Acrux
7/28/2021	Sabril	Vigabatrin	Lundbeck	Specgx
7/28/2021	Actigall	Ursodiol	AbbVie	Vgyaan
7/29/2021	Sabril	Vigabatrin	Lundbeck	Navisci
7/29/2021	CellCept	Mycophenolate Mofetil	Roche	Lannett
7/29/2021	Emend	Fosaprepitant Dimeglumine	Merck	Aspiro
7/29/2021	Paraflex	Chlorzoxazone	Ortho McNeil	Senores Pharms
7/29/2021	Faslodex	Fulvestrant	AstraZeneca	Zydus
7/30/2021	Potassium Chloride 10meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container	Potassium Chloride 10meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container	ICU Medical	Fresenius Kabi
7/30/2021	Potassium Chloride 20meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container	Potassium Chloride 20meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container	ICU Medical	Fresenius Kabi
8/02/2021	Detrol	Tolterodine Tartrate	Pfizer	Hetero Labs
8/02/2021	BiCNU	Carmustine	Emcure	Meitheal
8/03/2021	Belbuca	Buprenorphine HCl	Biodelivery	Alvogen
8/03/2021	Duexis	Ibuprofen / Famotidine	Horizon	Alkem
8/03/2021	Nicorette	Nicotine Polacrilex	Glaxo	Aurobindo
8/03/2021	Glumetza	Metformin HCl	Santarus	Amta
8/04/2021	Kadian	Morphine Sulfate	AbbVie	Nortec Dev
8/04/2021	Anafranil	Clomipramine HCl	SpecGx	Alembic
8/04/2021	Hexadrol	Dexamethasone / Sodium Phosphate	Aspen Global	Gland Pharma
8/06/2021	Effexor XR	Venlafaxine HCl	Upjohn	Yichang Humanwell
8/9/2021	Cuvposa	Glycopyrrolate	Merz	Par
8/9/2021	Durezol	Difluprednate	Novartis	Cipla
8/9/2021	Namenda XR	Memantine HCl	AbbVie	Aurobindo
8/10/2021	Epaned O.S.	Enalapril Maleate	Silver	Bionpharma
8/11/2021	Chantix	Varenicline	Pfizer	Par
8/11/2021	Aggrenox	Aspirin / Dipyridamole	Boehringer-Ingelheim	Micro Labs
8/11/2021	Imodium	Loperamide HCl	Johnson & Johnson	Strides Pharma
8/11/2021	Glucophage XR	Metformin HCl	EMD Serono	Unichem
8/11/2021	Paxil CR	Paroxetine HCl	Glaxo	Sinotherapeutics
8/12/2021	Colcrys	Colchicine	Takeda	Par
8/12/2021	Apriso	Mesalamine	Bausch & Lomb	Zydus
8/13/2021	Colcrys	Colchicine	Takeda	Hetero Labs
8/13/2021	Syprine	Trientine HCl	Bausch & Lomb	Eci Pharms
8/13/2021	Clindagel	Clindamycin Phosphate	Bausch & Lomb	Solaris Pharma
8/13/2021	Faslodex	Fulvestrant	AstraZeneca	Xiromed
8/13/2021	Lupron	Leuprolide Acetate	AbbVie	Vgyaan
8/13/2021	Daraprim	Pyrimethamine	Vyera	Teva
8/16/2021	Sutent	Sunitinib Malate	Pfizer	Sun Pharm
8/16/2021	Tegretol	Carbamazepine	Novartis	Vgyaan
8/17/2021	Mykacet	Nystatin / Triamcinolone Acetonide	Cossette	Macleod
8/18/2021	Trandate	Labetalol HCl	Alvogen	Rubicon
8/19/2021	Cuprimine	Penicillamine	Bausch & Lomb	Invagen Pharms
8/19/2021	Xeljanz XR	Tofacitinib	Pfizer	Zydus
8/19/2021	Diamox	Acetazolamide	Teva	Rubicon
8/20/2021	Symmetrel	Amantadine HCl	Endo	Invatech
8/20/2021	Rubramin PC	Cyanocobalamin	Bristol-Myers Squibb	Xiromed
8/20/2021	Zaroxolyn	Metolazone	Lannett	Rubicon
8/23/2021	Cuprimine	Penicillamine	Bausch	Aggrega
8/24/2021	Latuda	Lurasidone HCl	Sunovion	Dr Reddys Labs
8/24/2021	Aramine	Metaraminol Bitartrate	Merck	Slayback
8/24/2021	Cubicin	Daptomycin	Merck	Qilu
8/25/2021	Ortho Evra	Onsura	Janssen	Teva
8/25/2021	Tylenol	Acetaminophen	Johnson & Johnson	Marksans Pharma
8/26/2021	Topamax	Topiramate	Janssen	Ascent Pharms
8/27/2021	Paxil CR	Paroxetine HCl	Apotex	Cadila Pharms
8/30/2021	Jentadueto	Linagliptin / Metformin HCl	Boehringer-Ingelheim	Sunshine
8/30/2021	Protonix	Pantoprazole Sodium	Wyeth	ACIC Pharms
8/30/2021	Tamiflu	Oseltamivir Phosphate	Roche	Aptapharma
8/30/2021	Syprine	Trientine HCl	Bausch	Accord Healthcare
8/31/2021	Tradjenta	Linagliptin	Boehringer-Ingelheim	Sunshine
8/31/2021	Bactroban	Mupirocin	Glaxo	Encube
9/02/2021	Cubicin	Daptomycin	Merck	Eugia Pharma
9/02/2021	Lipitor	Atorvastatin Calcium	Upjohn	August
9/03/2021	Axiron	Testosterone	Eli Lilly	TWi Pharms
9/03/2021	Metrogel	Metronidazole	Galderma	Aleor Dermaceuticals
9/03/2021	Aralen	Chloroquine Phosphate	Sanofi Aventis	Suven Pharms
9/03/2021	Precedex	Dexmedetomidine HCl	Hospira	Piramal
9/03/2021	Paxil	Paroxetine HCl	Apotex	Novitium Pharma
9/7/2021	Integrilin	Eptifibatide	Schering	Shuangcheng
9/7/2021	Evekeo	Amphetamine Sulfate	Arbor	Rhodes Pharms
9/7/2021	Normodyne	Labetalol HCl	Schering	Caplin
9/8/2021	Xylocaine with epinephrine	Lidocaine HCl / Epinephrine	Fresenius Kabi	B Braun Medical
9/8/2021	Cerdelga	Eliglustat Tartrate	Sanofi	Aizant
9/8/2021	Halog	Halcinonide	Sun	Glasshouse Pharms
9/10/2021	Imodium	Loperamide HCl / Simethicone	Johnson & Johnson	Bionpharma
9/13/2021	Atripla	Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Macleods
9/13/2021	Motrin	Ibuprofen	McNeil	Alkem
9/17/2021	Trintellix	Vortioxetine Hydrobromide	Takeda	Zydus
9/17/2021	Quinaglute ER	Quinidine Gluconate	Bayer	Eywa
9/17/2021	Ofirmev	Acetaminophen	Mallinckrodt	Baxter Healthcare
9/20/2021	Evoclin	Clindamycin Phosphate	Mylan	Glenmark
9/20/2021	Tricor	Fenofibrate	AbbVie	Aurobindo
9/20/2021	Dacogen	Decitabine	Otsuka	Eugia Pharma
9/21/2021	Medrol	Methylprednisolone	Pfizer	Amneal
9/21/2021	Teflaro	Ceftaroline Fosamil	AbbVie	Apotex
9/21/2021	Otezla	Apremilast	Amgen	Alkem
9/21/2021	Otezla	Apremilast	Amgen	Zydus
9/21/2021	Absorica	Isotretinoin	Sun	Upsher Smith Labs
9/22/2021	Compazine	Prochlorperazine Edisylate	Glaxo	Gland Pharma
9/23/2021	Myfortic	Mycophenolic Acid	Novartis	Alkem
9/23/2021	Mirvaso	Brimonidine Tartrate	Galderma	Padagis
9/23/2021	Butrans	Buprenorphine	Purdue	Aveva
9/23/2021	Sabril	Vigabatrin	Lundbeck	Dexcel Pharma
9/24/2021	Aubagio	Teriflunomide	Sanofi	Breckenridge
9/28/2021	Compazine	Prochlorperazine Edisylate	Glaxo	Viwit Pharm
9/29/2021	Fortamet	Metformin HCl	Andrx	TWi Pharms
9/29/2021	Sabril	Vigabatrin	Lundbeck	Aurobindo
9/29/2021	Adderall XR	Detroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate	Takeda	Ascent Pharms
9/30/2021	Zomig	Zolmitriptan	AstraZeneca	Padagis
9/30/2021	Tegretol XR	Carbamazepine	Novartis	Anbison Lab