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

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

Second 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
4/1/2021	Tobi	Tobramycin	Mylan	Alkem
4/1/2021	Sinequan	Doxepin HCl	Pfizer	Appco
4/2/2021	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Cipla
4/2/2021	Namenda XR	Memantine HCl	AbbVie	Yichang Humanwell
4/2/2021	Kybella	Deoxycholic Acid	Kythera	Slayback
4/2/2021	Dermotic / Derma-Smooth FS	Fluocinolone Acetonide	Hill	Solaris Pharma
4/5/2021	Bloxiverz	Neostigmine Methylsulfate	Exela	Meitheal
4/6/2021	Opsumit	Macitentan	Actellion	Zydus
4/7/2021	Viibryd	Vilazodone HCl	AbbVie	Invagen Pharms
4/8/2021	Aggrastat	Tirofiban HCl	Medicure	Gland Pharma
4/8/2021	Cardene	Nicardipine HCl	Chiesi	Aurobindo
4/8/2021	Amicar	Aminocaproic Acid	Akorn	Airis Pharma
4/12/2021	Dacogen	Decitabine	Otsuka	Qilu
4/12/2021	Absorica	Isotretinoin	Sun	Upsher Smith Labs
4/13/2021	Lyrica CR	Pregabalin	Pfizer	Alvogen Pine Brook
4/13/2021	Lyrica CR	Pregabalin	Pfizer	Sun Pharm
4/13/2021	Lyrica CR	Pregabalin	Pfizer	Mylan
4/13/2021	Lyrica CR	Pregabalin	Pfizer	MSN
4/13/2021	Lyrica CR	Pregabalin	Pfizer	Apotex
4/13/2021	Tegretol XR	Carbamazepine	Novartis	CSPC Ouyi
4/14/2021	Pulmicort Respules	Budesonide	Sun	Sun Pharm
4/14/2021	Miralax	Polyethylene Glycol 3350	Bayer	Annora Pharma
4/15/2021	Acetadote	Acetylcysteine	Exela	Exela Pharma
4/16/2021	Glumetza	Metformin HCl	Bausch & Lomb	Sciegen Pharms
4/16/2021	Primacor	Milrinone Lactate	Sanofi Aventis	Caplin
4/20/2021	Solu Medrol	Methylprednisolone Sodium Succinate	Pfizer	Tianjin Kingyork
4/20/2021	Xylocaine	Lidocaine	AstraZeneca	Quagen
4/20/2021	Bloxiverz	Neostigmine Methylsulfate	Exela	Caplin
4/20/2021	Pepcid	Famotidine	Salix	Novitium Pharma
4/21/2021	Xyzal	Levocetirizine HCl	Sanofi Aventis	Apotex
4/21/2021	Cubicin	Daptomycin	Cubist	Hisun Pharm Hangzhou
4/21/2021	Foscavir	Foscarnet Sodium	Pfizer	Gland Pharma
4/21/2021	Rythmol SR	Propafenone HCl	GlaxoSmithKline	Zydus
4/21/2021	Sinequan	Doxepin HCl	Pfizer	Alembic Pharms
4/22/2021	Adderall	Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate	Teva	Ascent Pharms
4/22/2021	Compazine	Prochlorperazine Edisylate	GlaxoSmithKline	Caplin
4/23/2021	Rheumatrex	Methotrexate Sodium	Endo	Lotus Pharm
4/23/2021	Bentyl	Dicyclomine HCl	Adare	Novitium Pharma
4/26/2021	Magnesium Sulfate	Magnesium Sulfate	Hospira	B Braun Medical
4/26/2021	Lescol XL	Fluvastatin Sodium	Novartis	Beijing
4/26/2021	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch & Lomb	Alkem Labs
4/26/2021	Thiola	Tiopronin	Mission Pharma	Teva
4/27/2021	Viibryd	Vilazodone HCl	AbbVie	Accord Healthcare
4/28/2021	Duac	Clindamycin Phosphate / Benzoyl Peroxide	Glaxo	Encube
4/28/2021	Northera	Droxidopa	Lundbeck	Bionpharma
4/29/2021	Lidoderm	Lidocaine	Teikoku Pharma	Nal Pharm
4/29/2021	Revatio	Sildenafil Citrate	Pfizer	Appco
4/30/2021	Reyataz	Atazanavir Sulfate	Bristol-Myers Squibb	Laurus Labs
4/30/2021	Robaxin	Methocarbamol	Auxilium	MLV
4/30/2021	Sanctura XR	Trospium Chloride	Allergan	AMTA
5/3/2021	Nitrostat	Nitroglycerin	Pfizer	Rubicon
5/3/2021	Butrans	Buprenorphine	Purdue	Mylan
5/3/2021	Zoloft	Sertraline HCl	Upjohn	Ascent Pharms
5/4/2021	Focalin XR	Dexmethylphenidate HCl	Novartis	Mylan
5/4/2021	Cosopt	Dorzolamide HCl / Timolol Maleate	Akorn	Alembic Pharms
5/5/2021	Northera	Droxidopa	Lundbeck	Tris Pharma
5/6/2021	Onfi	Clobazam	Lundbeck	Alkem Labs
5/6/2021	Levophed	Norepinephrine Bitartrate	Hospira	Gland Pharma
5/7/2021	Claritin	Loratadine	Bayer	Hetero Labs
5/7/2021	Kerydin	Tavaborole	Anacor	Taro Pharms
5/7/2021	Sinemet	Carbidopa / Levodopa	Merck Sharp and Dohme	Sciegen Pharms
5/10/2021	Arava	Leflunomide	Sanofi Aventis	Aet Pharma
5/10/2021	Tarceva	Erlotinib HCl	Roche	MSN
5/10/2021	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch & Lomb	Dr Reddy's
5/10/2021	Neurontin	Gabapentin	Upjohn	Ascent Pharms
5/11/2021	Banzel	Rufinamide	Eisai	Hetero Labs
5/11/2021	Revatio	Sildenafil Citrate	Upjohn	Hetero Labs
5/11/2021	Onfi	Clobazam	Lundbeck	MSN
5/13/2021	Latuda	Lurasidone HCl	Sunovion	Alembic Pharms
5/13/2021	Tygacil	Tigecycline	PF Prism	Hong Kong
5/13/2021	Sabril	Vigabatrin	Lundbeck	Dexcel Pharma
5/14/2021	Cosopt	Dorzolamide HCl / Timolol Maleate	Akorn	Aurobindo
5/14/2021	Xtandi	Enzalutamide	Astellas	Actavis
5/14/2021	Miacalcin	Calcitonin-Salmon	Mylan	Custopharm
5/14/2021	Jadenu	Deferasirox	Novartis	Annora Pharma
5/17/2021	Renvela	Sevelamer Carbonate	Genzyme	Bionpharma
5/18/2021	Nebcin	Tobramycin Sulfate	Eli Lilly	Gland Pharma
5/18/2021	Ranexa	Ranolazine	Gilead	Accord Healthcare
5/19/2021	Isuprel	Isoproterenol HCl	Bausch & Lomb	Amring Pharms
5/19/2021	Zovirax	Acyclovir	Bausch & Lomb	Macleods
5/19/2021	Amitid	Amitriptyline HCl	BMS	Unichem
5/20/2021	Zortress	Everolimus	Novartis	Breckenridge
5/20/2021	Ketozole	Ketoconazole	Taro	Encube
5/21/2021	Revlimid	Lenalidomide	Celgene	Natco Pharma
5/21/2021	Augmentin	Amoxicillin / Clavulanate Potassium	US Antibiotics	Micro Labs
5/21/2021	Zinc Chloride	Zinc Chloride	Hospira	Exela Pharma
5/21/2021	Firazyr	Icatibant Acetate	Shire	Glenmark
5/21/2021	Extina	Ketoconazole	Mylan	Xiromed
5/27/2021	Jadenu	Deferasirox	Novartis	Celltrion
5/27/2021	Imodium	Loperamide HCl / Simethicone	Johnson & Johnson	Guardian Drug
5/27/2021	Permitil	Fluphenazine HCl	Schering	Zydus
5/28/2021	Vicoprin	Hydrocodone Bitartrate / Aspirin	Abbott	LGM Pharma
5/28/2021	Alkeran	Melphalan HCl	Apotex	Hong Kong
5/28/2021	Angiomax	Bivalirudin	Sandoz	Hainan Poly Pharm
6/1/2021	Proventil HFA	Albuterol Sulfate	Kindeva	Sandoz
6/1/2021	Xeljanz	Tofacitinib Citrate	PF Prism	Ajanta Pharma
6/2/2021	Mycamine	Micafungin Sodium	Astellas	Xellia Pharms
6/2/2021	Oxycodone HCl	Oxycodone HCl	Genus	Quagen
6/2/2021	Thorazine	Chlorpromazine HCl	Glaxo	Genus
6/3/2021	Theophylline	Theophylline	Alembic	Glenmark
6/4/2021	Kaletra	Lopinavir / Ritonavir	AbbVie	Hetero Labs
6/4/2021	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Lupin
6/7/2021	Zenzendi	Dextroamphetamine Sulfate	Arbor	Winder Labs
6/10/2021	Effexor XR	Venlafaxine HCl	Osmotica	Alkem Labs
6/11/2021	Kyprolis	Carfilzomib	Amgen	Breckenridge
6/11/2021	Faslodex	Fulvestrant	AstraZeneca	Apotex
6/11/2021	Mirapex ER	Pramipexole Dihydrochloride	Boehringer-Ingelheim	Xiamen LP Pharm
6/11/2021	Keppra	Levetiracetam	UCB	Sciegen Pharms
6/14/2021	Amicar	Aminocaproic Acid	Akorn	Edenbridge Pharms
6/14/2021	Axiron	Testosterone	Eli Lilly	Aleor Dermaceuticals
6/14/2021	Intelence	Etravirine	Johnson & Johnson	Amneal
6/14/2021	Akovaz	Ephedrine Sulfate	Exela	Aurobindo
6/14/2021	Clobex	Clobetasol Propionate	Galderma	Amneal
6/15/2021	Kuvan	Sapropterin Dihydrochloride	Biomarin	Dr Reddy's
6/15/2021	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Alkem
6/16/2021	Sustiva	Efavirenz	Bristol-Myers Squibb	Strides
6/16/2021	Boniva	Ibandronate Sodium	Roche	Nang Kuang
6/16/2021	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Apotex
6/16/2021	Renagel	Sevelamer HCl	Genzyme	Lupin
6/17/2021	Imodium	Loperamide HCl / Simethicone	Johnson & Johnson	Hetero Labs
6/17/2021	Levo-Dromoran	Levorphanol Tartrate	Valeant	Sun Pharm
6/21/2021	Jublia	Efinaconazole	Bausch & Lomb	Acrux DDS
6/21/2021	Trileptal	Oxcarbazepine	Novartis	Glasshouse Pharms
6/22/2021	Perforomist	Formoterol Fumarate	Mylan	Teva
6/22/2021	Brovana	Arformoterol Tartrate	Sunovion	Cipla
6/22/2021	Brovana	Arformoterol Tartrate	Sunovion	Glenmark
6/22/2021	Brovana	Arformoterol Tartrate	Sunovion	Axar Pharms
6/25/2021	Gemzar	Gemcitabine HCl	Eli Lilly	Hikma
6/25/2021	Macrodantin	Nitrofurantoin	Almatica	Alembic
6/25/2021	Taxotere	Docetaxel	Sanofi Aventis	Eugia Pharma
6/28/2021	Cleocin T	Clindamycin Phosphate	Pfizer	Taro Pharms
6/29/2021	Aloxi	Palonosetron HCl	Eli Lilly	Emcure
6/29/2021	Aptiom	Eslicarbazepine Acetate	Sunovion	Dr Reddys
6/29/2021	Cubicin	Daptomycin	Cubist	Hong Kong
6/29/2021	Cubicin	Daptomycin	Sagent	Hong Kong
6/30/2021	Vascepa	Icosapent Ethyl	Amarin	Apotex
6/30/2021	Otezla	Apremilast	Amgen	Amneal
6/30/2021	Effexor XR	Venlafaxine HCl	Wyeth	Appco