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

Fourth 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
10/01/2020	Diamox	Acetazolamide	Teva	Micro Labs
10/01/2020	Proamatine	Midodrine HCl	Takeda	Xiromed
10/02/2020	Nexium	Esomeprazole Magnesium	AstraZeneca	CSPC Ouyi
10/02/2020	Anafril	Clomipramine HCl	SpecGx	Ajanta Pharma
10/06/2020	Acticlate	Doxycycline Hyclate	Almirall	Mylan
10/06/2020	Tecfidera	Dimethyl Fumarate	Biogen	Lupin
10/06/2020	Tecfidera	Dimethyl Fumarate	Biogen	Glenmark
10/06/2020	Methylin ER	Methylphenidate HCl	SpecGx	Alkem Labs
10/06/2020	Monurol	Fosfomycin Tromethamine	Zambon	Xiromed
10/06/2020	Akovaz	Ephedrine Sulfate	Exela	Dr Reddy's Labs
10/06/2020	Firazyr	Icatibant Acetate	Shire	Dr Reddy's Labs
10/06/2020	Lomotil	Diphenoxylate HCl / Atropine Sulfate	Pfizer	Specgx
10/06/2020	Ultravate	Halobetasol Propionate	Sun Pharma	Quagen
10/07/2020	Sensipar	Cinacalcet HCl	Amgen	Hetero Labs
10/07/2020	Finacea	Azelaic Acid	Leo	Teva
10/07/2020	Diamox	Acetazolamide	Teva	Mankind
10/08/2020	Proventil	Albuterol Sulfate	Schering Plough	Eywa
10/08/2020	Phernagen with Codeine	Promethazine HCl / Codeine Phosphate	ANI Pharma	Quagen
10/09/2020	Nordette-28	Levonorgestrel / Ethinyl Estradiol	Teva	Naari Pte
10/09/2020	Lioresal	Baclofen	Novartis	Innogenix
10/13/2020	Ultiva	Remifentanil HCl	Mylan	Navinta
10/13/2020	Kerydin	Tavaborole	Anacor	Encube
10/13/2020	Kerydin	Tavaborole	Anacor	Perrigo
10/14/2020	Gilenya	Fingolimod HCl	Novartis	Zydus
10/14/2020	Tecfidera	Dimethyl Fumarate	Biogen	Twi
10/15/2020	Isoptin	Verapamil HCl	Mt Adams Tech	Zydus
10/15/2020	Symmetrel	Amantadine HCl	Endo	Alembic Pharms
10/15/2020	Isoptin	Verapamil HCl	Mt Adams Tech	Gland Pharma
10/16/2020	Rapamune	Sirolimus	Pfizer	Glenmark Pharms
10/16/2020	Sinequan	Doxepin HCl	Pfizer	Epic Pharma
10/16/2020	Actigall	Ursodiol	Allergan	Zydus
10/19/2020	Vesicare	Solifenacin Succinate	Astellas	Zydus
10/19/2020	Levo T	Levothyroxine Sodium	Cediprof	Accord Healthcare
10/19/2020	Tricor (Micronized)	Fenofibrate (Micronized)	AbbVie	Alembic Pharms
10/19/2020	Advil	Ibuprofen	Glaxo	Yichang Humanwell
10/20/2020	Toradol	Ketorolac Tromethamine	Roche	Aurobindo Pharma
10/20/2020	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch & Lomb	ECI Pharms
10/20/2020	Halcion	Triazolam	Pharmacia/Upjohn	Riconpharma
10/21/2020	Lomotil	Diphenoxylate HCl / Atropine Sulfate	Pfizer	ECI Pharms
10/21/2020	Ofirmev	Acetaminophen	Mallinckrodt	Aurobindo Pharma
10/21/2020	Emend	Aprepitant	Merck	Torrent
10/21/2020	Kerydin	Tavaborole	Anacor	Aleor Dermaceuticals / Alembic
10/21/2020	Skelaxin	Metaxalone	Pfizer	Ingenus Pharms
10/21/2020	Venlafaxine HCl	Venlafaxine HCl	Osmotica	Ascent Pharms
10/21/2020	Klor-Con	Potassium Chloride	Upsher-Smith	Granules
10/22/2020	Lybrel	Dolishale Levonorgestrel / Ethinyl Estradiol	Wyeth	Novast Labs
10/22/2020	Uloric	Febuxostat	Takeda	Dr Reddys Labs
10/22/2020	Proventil	Albuterol Sulfate	Schering Plough	Zydus Pharms
10/22/2020	Zyprexa	Olanzapine	Eli Lilly	Aurobindo Pharma
10/22/2020	Timoptic XE	Timolol Maleate	Bausch & Lomb	Alembic Pharms
10/22/2020	BiCNU	Carmustine	Emcure	Dr Reddys Labs
10/22/2020	Wellcovorin	Leucovorin Calcium	Glaxo	Leading Pharma
10/23/2020	Zetia	Ezetimibe	Merck	Sciegen Pharms
10/23/2020	Cialis	Tadalafil	Eli Lilly	Umedica Labs
10/23/2020	Zyflo CR	Zileuton	Chiesi	Aizant
10/23/2020	Busulfex	Busulfan	Otsuka	Meitheal/Nanjing King-Friend
10/23/2020	Clolar	Clofarabine	Genzyme	Hong Kong
10/26/2020	Rozarem	Ramelteon	Takeda	Appco
10/26/2020	Thorazine	Chlorpromazine HCl	Upsher-Smith	Sun Pharm
10/27/2020	Magnesium Sulfate in Dextrose 5% in Plastic Container	Magnesium Sulfate in Dextrose 5% in Plastic Container	Hospira	B Braun Medical
10/27/2020	Cialis	Tadalafil	Eli Lilly	Yangling Buchang
10/27/2020	Nimbex Preservative Free	Cisatracurium Besylate Preservative Free	AbbVie	Aurobindo
10/27/2020	Dibenzyline	Phenoxybenzamine HCl	Concordia	Amneal
10/27/2020	Quelicin	Succinylcholine Chloride	Pfizer	Nexus Pharms
10/27/2020	Evekeo	Amphetamine Sulfate	Arbor	Alkem Labs
10/27/2020	Evekeo	Amphetamine Sulfate	Arbor	Epic Pharma
10/27/2020	Ditropan XL	Oxybutynin Chloride	Johnson & Johnson	Rubicon
10/28/2020	Gilenya	Fingolimod HCl	Novartis	Accord Healthcare
10/28/2020	Tirosint	Levothyroxine Sodium	IBSA	Teva
10/28/2020	Ritalin	Methylphenidate HCl	Novartis	Accord Healthcare
10/29/2020	Nitropress	Sodium Nitroprusside	Hospira	Xiromed
10/29/2020	Invega	Paliperidone	Janssen	CSPC Ouyi
10/30/2020	Singulair	Montelukast Sodium	Merck	Laboratorios Liomont
10/30/2020	Pomalyst	Pomalidomide	Celgene	Breckenridge
10/30/2020	Pomalyst	Pomalidomide	Celgene	Eugia Pharma/ Aurobindo
10/30/2020	Edecrin	Ethacrynic Acid	Bausch & Lomb	Strides
10/30/2020	Claritin Reditabs	Loratadine	Bayer	Tenshi
11/02/2020	Methadose	Methadone HCl	SpecGx	Lannett
11/02/2020	Vidaza	Azacitidine	Celgene	Meitheal
11/02/2020	Parafone Forte	Chlorzoxazone	Mikart	Par
11/02/2020	Camptosar	Irinotecan HCl	Pfizer	Eugia Pharma
11/03/2020	Bystolic	Nebivolol HCl	Allergan	Hetero Labs
11/03/2020	Levophed	Norepinephrine Bitartrate	Hospira	Fresenius Kabi
11/05/2020	Bromfed DM	Brompheniramine Maleate / Pseudoephedrine HCl / Dextromethorphan Hydrobromide	Wockhardt	Rhodes Pharms
11/05/2020	Mycamine	Micafungin Sodium	Astellas	Apotex
11/05/2020	Fetzima	Levomilnacipran HCl	Allergan	Hikma
11/06/2020	Nimbex Preservative Free	Cisatracurium Besylate	AbbVie	Sagent Pharms
11/06/2020	Nimbex	Cisatracurium Besylate	AbbVie	Sagent Pharms
11/06/2020	Toprol-XL	Metoprolol Succinate	Aralez	Hetero Labs
11/06/2020	Amicar	Aminocaproic Acid	Akorn	MSN
11/09/2020	Tarceva	Erlotinib HCl	Genentech	Teva
11/09/2020	Zovirax	Acyclovir	Bausch & Lomb	Amneal
11/09/2020	Taytulla	Norethindrone Acetate / Ethinyl Estradiol	Allergan	Chemo Research
11/10/2020	Prograf	Tacrolimus	Astellas	Glenmark
11/10/2020	Prograf	Tacrolimus	Astellas	Biocon Pharma
11/10/2020	Prograf	Tacrolimus	Astellas	Concord Biotech/Lupin
11/10/2020	Kenalog	Triamcinolone Acetonide	CMP Pharma	Cintex Svcs
11/10/2020	Cleocin T	Clindamycin Phosphate	Pfizer	Taro Pharms
11/12/2020	Prograf	Tacrolimus	Astellas	Alkem Labs
11/12/2020	Nexavar	Sorafenib Tosylate	Bayer	Teva
11/12/2020	Questran Light	Cholestyramine Light	Bristol-Myers Squibb	Tagi
11/12/2020	Astepro	Azelastine HCl	Mylan	Aurobindo
11/13/2020	Vazculep	Phenylephrine HCl	Exela	Aurobindo
11/13/2020	Cosmogen	Dactinomycin	Recordati Rare Diseases	Hong Kong
11/13/2020	Sabril	Vigabatrin	Lundbeck	Accord Healthcare
11/17/2020	Depakote	Divalproex Sodium	AbbVie	Teva
11/17/2020	Faslodex	Fulvestrant	AstraZeneca	Accord Healthcare
11/18/2020	Procardia XL	Nifedipine	Pfizer	Elite
11/18/2020	Nexium	Esomeprazole Magnesium	AstraZeneca	Amta
11/20/2020	Deltasone	Prednisone	Pharmacia/Upjohn	Strides
11/20/2020	Renvela	Sevelamer Carbonate	Genzyme	Impax/Amneal
11/20/2020	Quelicin	Succinylcholine Chloride	Pfizer	Fresenius Kabi
11/23/2020	Dacogen	Decitabine	Otsuka	Apotex
11/23/2020	Precedex	Dexmedetomidine HCl	Hospira	Tagi
11/23/2020	Cialis	Tadalafil	Eli Lilly	Sunshine
11/24/2020	Lodine XL	Etodolac	Wyeth	Bayshore Pharms
11/24/2020	Transderm SCOP	Scopolamine	Glaxo	Riconpharma
11/24/2020	Quelicin	Succinylcholine Chloride	Pfizer	Micro Labs
11/25/2020	Viagra	Sildenafil Citrate	Upjohn	Watson
11/25/2020	Axiron	Testosterone	Eli Lilly	Apotex
11/25/2020	Toprol-XL	Metoprolol Succinate	Aralez	Alkem Labs
11/25/2020	Kerydin	Tavaborole	Anacor	Amneal
11/25/2020	Tenoretic	Atenolol / Chlorthalidone	Almatica	Unichem
11/25/2020	Intuniv	Guanfacine HCl	Takeda	Yichang Humanwell
11/27/2020	Kepra XR	Levetiracetam	UCB	Sciegen Pharms
11/27/2020	Azopt	Brinzolamide	Novartis	Watson
11/27/2020	Hiprex	Methenamine Hippurate	Validus	Riconpharma
11/27/2020	Alinia	Nitazoxanide	Romark	Rising
11/27/2020	Hygroton	Chlorthalidone	Sanofi Aventis	Ajanta Pharma
11/30/2020	Wellbutrin XL	Bupropion HCl	Valeant	Sun Pharm
11/30/2020	Ranexa	Ranolazine	Gilead	Alkem Labs
11/30/2020	Depen	Penicillamine	Mylan	Lupin
12/1/2020	Lidoderm	Lidocaine	Teikoku	Noven Pharms
12/2/2020	Cuprimine	Penicillamine	Valeant	Granules
12/2/2020	Diulo	Metolazone	GD Searle	Alembic Pharms
12/2/2020	Sabril	Vigabatrin	Lundbeck	Alkem Labs
12/3/2020	Celebrex	Celecoxib	GD Searle	Sciegen Pharms
12/3/2020	Acular	Ketorolac Tromethamine	Allergan	Aurobindo
12/3/2020	Norvir	Ritonavir	AbbVie	Hikma
12/3/2020	Morphine Sulfate	Morphine Sulfate	Hikma	Alkem Labs
12/4/2020	Xeloda	Capecitabine	Hoffman La Roche	Dr Reddys Labs
12/4/2020	Welchol	Colesevelam HCl	Daiichi Sankyo	Inventia
12/4/2020	Xenazine	Tetrabenazine	Bausch & Lomb	Ajanta Pharma
12/7/2020	Precedex	Dexmedetomidine HCl	Pfizer	Aurobindo
12/7/2020	Dacogen	Decitabine	Otsuka	Nivagen Pharms
12/8/2020	Emend IV	Fosaprepitant Dimeglumine	Merck	Sandoz
12/8/2020	Rubramin PC	Cyanocobalamin	Bristol-Myers Squibb	Aurobindo
12/9/2020	Afinitor	Everolimus	Novartis	Par Pharm
12/9/2020	Emend IV	Fosaprepitant Dimeglumine	Merck	Dr Reddys Ltd
12/9/2020	Onfi	Clobazam	Lundbeck	Celltrion
12/9/2020	Celebrex	Celecoxib	GD Searle	Acic Pharms
12/10/2020	Saphris	Asenapine Maleate	AbbVie	Breckenridge
12/10/2020	Saphris	Asenapine Maleate	AbbVie	Alembic Pharms
12/10/2020	Saphris	Asenapine Maleate	AbbVie	Sigmapharm Labs
12/10/2020	Acticlate	Doxycycline Hyclate	Almirall	Nostrum Labs
12/10/2020	Nitropress	Sodium Nitroprusside	Hospira	Aurobindo Pharma
12/10/2020	Prilosec	Omeprazole	P&G	Xiromed
12/11/2020	Namenda	Memantine HCl	Allergan	Polygen Pharms
12/11/2020	Gemcitabine HCl	Gemcitabine HCl	Hospira	Nanjing King-Friend
12/11/2020	Versed	Midazolam HCl	Hoffman La Roche	Hikma
12/14/2020	Immodium Multi-Symptom Relief	Loperamide Hydrochloride / Simethicone	Johnson & Johnson	Aurobindo Pharma
12/14/2020	Amicar	Aminocaproic Acid	Akorn	ANI Pharms
12/15/2020	Renagel	Sevelamer HCl	Genzyme	Mylan
12/15/2020	Akovaz	Ephedrine Sulfate	Exela	Hikma
12/16/2020	Methylin	Methylphenidate HCl	SpecGx	Lannett
12/16/2020	Lodine	Etodolac	Wyeth	Bayshore Pharms
12/16/2020	Jublia	Efinaconazole	Bausch & Lomb	Teva
12/16/2020	Jublia	Efinaconazole	Bausch & Lomb	Perrigo
12/16/2020	Firazyr	Icatibant Acetate	Shire	Nang Kuang Pharm
12/16/2020	Acticlate	Doxycycline Hyclate	Almirall	Epic Pharma
12/17/2020	Vytorin	Ezetimibe / Simvastatin	Merck	Mylan
12/17/2020	Welchol	Colesevelam HCl	Daiichi Sankyo	Lupin
12/17/2020	Advair Diskus	Fluticasone Propionate / Salmeterol Xinafoate	Glaxo	Hikma
12/17/2020	Ditropan	Oxybutynin Chloride	Janssen	Strides Pharma
12/18/2020	Gilenya	Fingolimod HCl	Novartis	Apotex
12/18/2020	Lasix	Furosemide	Sanofi Aventis	Areva Pharms
12/18/2020	Taytulla	Norethindrone Acetate / Ethinyl Estradiol	Allergan	Slayback Pharma
12/18/2020	Banzel	Rufinamide	Eisai	Lupin
12/18/2020	Apresoline	Hydralazine HCl	Novartis	Hikma
12/18/2020	Amidate	Etomidate	Pfizer	Caplin
12/21/2020	Quelicin	Succinylcholine Chloride	Pfizer	Deva Holding
12/23/2020	Trilipix	Fenofibric Acid	AbbVie	Yichang Humanwell
12/28/2020	Glucagon	Glucagon	Eli Lilly	Amphastar Pharms
12/28/2020	Latuda	Lurasidone HCl	Sunovion	Piramal Healthcare
12/29/2020	Cialis	Tadalafil	Eli Lilly	Glenmark
12/29/2020	Potassium Chloride	Potassium Chloride	Merck	Ascent Pharms
12/29/2020	Liquaemin Sodium	Heparin Sodium	Organon	Be Pharms
12/29/2020	Liquaemin Sodium	Heparin Sodium	Organon	Be Pharms
12/30/2020	Levaquin in Dextrose 5% in Plastic Container	Levofloxacin in Dextrose 5% in Plastic Container	Janssen	Gland Pharma
12/30/2020	Gilenya	Fingolimod HCl	Novartis	Alkem Labs
12/31/2020	Wellbutrin XL	Bupropion HCl	Valeant	Sun Pharm
12/31/2020	Zyprexa	Olanzapine	Eli Lilly	Pharmtak
12/31/2020	Zyprexa	Olanzapine	Eli Lilly	Pharmtak
12/31/2020	Cleocin T	Clindamycin Phosphate	Pfizer	Gage Development

GENERICally Speaking Winter 2021

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner

Christopher A. Pinahs

Partner

GENERICally Speaking Winter 2021

VOL. 10, NO. 4

First Quarter

ANDA Litigation Settlements