ANDA Approvals Spring 2019 | Hatch-Waxman | Robins Kaplan LLP Law Firm

Spring 2019

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
1/2/2019	Mirapex ER	Pramipexole Dihydrochloride	Boehringer Ingelheim	Alembic Pharms
1/3/2019	Latuda	Lurasidone HCl	Sunovion	Amneal
1/3/2019	Latuda	Lurasidone HCl	Sunovion	Invagen Pharms
1/3/2019	Latuda	Lurasidone HCl	Sunovion	Lupin
1/3/2019	Latuda	Lurasidone HCl	Sunovion	Accord Hlthcare
1/3/2019	Aubagio	Teriflunomide	Sanofi Aventis	Sandoz
1/3/2019	Dolophine	Methadone HCl	West-Ward Pharms	Ascent Pharms
1/4/2019	Naproxen Sodium	Naproxen Sodium (OTC)	Bionpharma	Catalent
1/4/2019	Latuda	Lurasidone HCl	Sunovion	Sun Pharma
1/4/2019	Rythmol SR	Propafenone HCl	GlaxoSmithKline	Sinotherapeutics
1/7/2018	Abilify	Aripiprazole	Otsuka	Zydus
1/7/2018	Zytiga	Abiraterone Acetate	Janssen	Amneal
1/7/2018	Picato	Ingenol Mebutate	Leo Labs	Perrigo UK Finco
1/7/2018	Aubagio	Teriflunomide	Sanofi Aventis	Accord Healthcare
1/8/2019	Exelon	Rivastigmine	Novartis	Amneal
1/8/2019	CellCept	Mycophenolate Mofetil	Roche	Concord Biotech
1/9/2019	Picato	Ingenol Mebutate	Leo Labs	Perrigo
1/9/2019	Medrol	Methylprednisolone	Pharmacia and Upjohn	RiconPharma
1/10/2019	Benicar	Olmesartan Medoxomil	Daiichi Sankyo	Qilu Pharm
1/10/2019	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Sciegen
1/11/2019	Caduet	Amlodipine Besylate / Atorvastatin Calcium	Pfizer	Zydus
1/11/2019	Betamethasone Dipropionate	Betamethasone Dipropionate	Fougera	Zydus
1/11/2019	Zovirax	Acyclovir	Bausch & Lomb	Torrent
1/11/2019	Femara	Letrozole	Novartis	Eugia Pharma
1/14/2019	Viramune	Nevirapine	Boehringer Ingelheim	MacLeods
1/14/2019	Microzide	Hydrochlorothiazide	Allergan Sales	Sciegen
1/14/2019	Busulfex	Busulfan	Otsuka	Nexus Pharms
1/14/2019	Lotronex	Alosetron HCl	Sebela	Rising Pharms
1/14/2019	Sabril	Vigabatrin	Lundbeck	Teva
1/15/2019	Relpax	Eletriptan Hydrobromide	Pfizer	Aurobindo
1/15/2019	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharms	Laurus Labs
1/16/2019	Diamox	Acetazolamide	Teva	Xylopia
1/16/2019	Effient	Prasugrel	Eli Lilly and Co	HEC Pharm
1/16/2019	Syprine	Trientine HCl	Aton	Navinta
1/17/2019	Gleevec	Imatinib Mesylate	Novartis	Shilpa Medicare
1/17/2019	Gleevec	Imatinib Mesylate	Novartis	Wockhardt
1/18/2019	Precedex	Dexmedetomidine HCl	Hospira	Cipla
1/18/2019	Prevacid	Lansoprazole	Takeda	Alkem Labs
1/18/2019	Levo-T / Synthroid / Thyro-Tabs/ Unithroid	Levothyroxine Sodium	Cediprof / AbbVie / Lloyd / Stevens	Lupin
1/18/2019	Cyclophosphamide	Cyclophosphamide	West-Ward Pharms	Cipla
1/18/2019	Zovirax	Acyclovir	Bausch & Lomb	Cipla
1/22/2019	Adderall XR	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Shire	Amerigen Pharms
1/22/2019	Klor-Con	Potassium Chloride	Upsher-Smith Labs	PII
1/22/2019	Tikosyn	Dofetilde	Pfizer	Aurobindo
1/22/2019	Retin-A	Tretinoin	Valeant	Taro Pharms
1/23/2019	Brilinta	Ticagrelor	AstraZeneca	Amneal
1/23/2019	Brilinta	Ticagrelor	AstraZeneca	Hisun Pharm Hangzhou
1/24/2019	Trusopt	Dorzolamide HCl	Merck	FDC
1/24/2019	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Alvogen Pine Brook
1/25/2019	Aleve PM	Naproxen Sodium / Diphenhydramine Chloride	Bayer Healthcare	Actavis
1/25/2019	Integrilin	Eptifibatide	Schering	Hainan Poly Pharm
1/25/2019	Bentyl	Dicyclomine HCl	Allergan	Fresenius Kabi
1/25/2019	Depo-Provera	Medroxyprogesterone Acetate	Pharmacia and Upjohn	Cipla
1/25/2019	Retin-A	Tretinoin	Valeant	Taro Pharms
1/25/2019	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Alvogen	Dr Reddy's Labs
1/25/2019	Zanaflex	Tizanidine HCl	Covis Pharma	Alkem Labs
1/25/2019	Lialda	Mesalamine	Shire	Sun Pharm
1/28/2019	Lactated Ringer's in Plastic Container	Sodium Chloride / Sodium Lactate / Potssium Chloride / Calcium Chloride in Water	Baxter Healthcare	Fresenius Kabi
1/28/2019	Cleocin T	Clindamycin Phosphate	Pharmacia and Upjohn	Encube Ethicals
1/28/2019	DDAVP	Desmopressin Acetate	Ferring Pharms	Abhai
1/28/2019	Wellbutrin XL	Bupropion HCl	Valeant	Graviti Pharms
1/28/2019	Rapamune	Sirolimus	PF Prism	Novitium Pharma
1/29/2019	Vazculep	Phenylephrine HCl	West-Ward Pharm / Avadel Legacy	Fresenius Kabi
1/30/2019	Advair	Wixela Inhub	Glaxo	Mylan
1/30/2019	Vazculep	Phenylephrine HCl	Avadel Legacy	Fresenius Kabi
1/30/2019	Desonide	Desonide	Perrigo	Encube Ethicals
1/30/2019	Onfi	Clobazam	Lundbeck	Micro Labs
1/31/2019	Vazculep	Phenylephrine HCl	West-Ward Pharm / Avadel Legacy	Sandoz
1/31/2019	Protopic	Tacrolimus	Leo Pharma	Accord Healthcare
2/1/2019	Bentyl	Dicyclomine HCl	Allergan	Nexus Pharms
2/1/2019	Ritalin	Methylphenidate HCl	Novartis	Cediprof
2/4/2019	Trandate	Labetalol HCl	County Line Pharms	Invatech Pharma
2/4/2019	Zovirax	Acyclovir	Bausch & Lomb	Perrigo
2/4/2019	Fetzima	Levomilnacipran HCl	Allergan	Amneal
2/4/2019	Oxycodone HCl	Oxycodone HCl	Genus Lifesciences	Alkem Labs
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Aurobindo
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Hetero
2/5/2019	Adcirca	Alyq	Eli Lilly and Co	Teva
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Dr Reddy's Labs
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Cipla
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Ajanta Pharma
2/5/2019	Adcirca	Tadalafil	Eli Lilly and Co	Lupin
2/5/2019	Vivelle-Dot	Estradiol	Novartis	Amneal
2/6/2019	Seasonale	Sylevia	Teva	Sun Pharm
2/7/2019	Tegretol-XR	Carbamazepine	Novartis	Zydus
2/7/2019	Nicorette	Nicotine Polacrilex	GlaxoSmithKline	PLD Acquisitions
2/7/2019	Benicar HCT	Olmesartan Medoxomil / Hydrochlorothiazide	Daiichi Sankyo	Accord Healthcare
2/7/2019	Oxycodone HCl	Oxycodone HCl	Genus Lifesciences / VistaPharm	Alkem Labs
2/8/2019	Renagel	Sevelamer HCl	Genzyme	Glenmark
2/8/2019	Gleevec	Imatinib Mesylate	Novartis	Breckenridge
2/8/2019	Gleevec	Imatinib Mesylate	Novartis	Amneal
2/8/2019	Ferriprox	Deferiprone	Apopharma	Taro Pharm
2/8/2019	Syprine	Trientine HCl	Aton	Amneal
2/8/2019	Colcrys	Colchicine	Takeda	Alkem Labs
2/8/2019	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Lupin
2/8/2019	Lipitor	Atorvastatin Calcium	Pfizer	MSN Labs
2/11/2019	Dyazide	Triamterene and Hydrochlorothiazide	GlaxoSmithKline	Zydus
2/11/2019	Omeprazole	Omeprazole (OTC)	Dexcel Pharma	Apotex
2/11/2019	Triamcinolone Acetonide	Triamcinolone Acetonide	Mylan	Strides Pharma
2/11/2019	Bentyl	Dicyclomine HCl	Allergan	Custopharm
2/12/2019	CellCept	Mycophenolate Mofetil	Roche	VistaPharm
2/13/2019	Vigamox	Moxifloxacin HCl	Novartis	Alembic Pharms
2/13/2019	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	Encube Ethicals
2/14/2019	DDAVP	Desmopressin Acetate	Ferring	Luitpold
2/14/2019	Gemcitabine HCl	Gemcitabine HCl	Hospira	Ingenus Pharms
2/14/2019	Advil PM	Ibuprofen / Diphenhydramine HCl	Pfizer	Aurobindo Pharma
2/15/2019	Eloxatin	Oxaliplatin	Sanofi Aventis / Teva	Sun Pharma
2/15/2019	Actonel	Risedronate Sodium	Apil	Hangzhou Binjiang
2/15/2019	Olux	Clobetasol Propionate	Mylan	Glenmark
2/19/2019	Micardis	Telmisartan	Boehringer Ingelheim	Hisun Pharm Hangzhou
2/19/2019	Diamox	Acetazolamide	Teva	Alembic Pharms
2/19/2019	Levo-T / Levoxyl / Synthroid / Unithroid	Levothyroxine Sodium	Cediprof / King Pharms / AbbVie / Stevens	Amneal
2/19/2019	Marcaine	Bupivacaine HCl	Hospira	Novocol Healthcare
2/19/2019	Colcrys	Colchicine	Takeda	Zydus
2/19/2019	Zarontin	Ethosuximide	Parke Davis	Strides
2/20/2019	Zovirax	Acyclovir	Bausch & Lomb	Perrigo
2/20/2019	Nimbex	Cisatracurium Besylate Preservative Free	AbbVie	Somerset Theraps
2/20/2019	Mephyton	Phytonadione	Bausch & Lomb	Zydus
2/21/2019	Rocaltrol	Calcitriol	Validus Pharms	Sun Pharm
2/21/2019	Abilify	Aripiprazole	Otsuka	Alkem Labs
2/21/2019	Aromasin	Exemestane	Pharmacia and Upjohn	Breckenridge
2/22/2019	Niaspan	Niacin	AbbVie	Mylan
2/22/2019	Antivert	Meclizine HCl	Casper Pharma	Indicus Pharma
2/22/2019	Gemzar	Gemcitabine HCl	Eli Lilly and Co	Shilpa Medicare
2/22/2019	Medrol	Methylprednisolone	Pharmacia and Upjohn	Lupin
2/22/2019	Cyklokapron	Tranexamic Acid	Pharmacia and Upjohn	Acic Pharms
2/22/2019	Busulfex	Busulfan	Otsuka	Accord Healthcare
2/22/2019	Benicar	Olmesartan Medoxomil	Daiichi Sankyo	Sunshine Lake
2/22/2019	Tessalon	Benzonatate	Pfizer	Ascent Pharms
2/22/2019	Clolar	Clofarabine	Genzyme	Accord Healthcare
2/25/2019	Flagyl I.V. RTU in Plastic Container / Metro I.V. in Plastic Container / Metronidazole in Plastic Container	Metronidazole in Plastic Container	Baxter Healthcare / B Braun / Hospira	Inforlife
2/25/2019	Lovaza	Omega-3-Acid Ethyl Esters	SmithKline Beecham	Ascent Pharms
2/25/2019	Zytiga	Abiraterone Acetate	Janssen	Rising Pharms
2/26/2019	Zithromax	Azithromycin	Pfizer	Bionpharma
2/26/2019	Zithromax	Azithromycin	Pfizer	Bionpharma
2/27/2019	Zytiga	Abiraterone Acetate	Janssen	Wockhardt
2/27/2019	Vidaza	Azacitidine	Celgene	Lupin
2/27/2019	Tamiflu	Oseltamivir Phosphate	Roche	Teva
2/28/2019	Ditropan XL	Oxybutynin Chloride	Janssen	Ajanta
3/1/2019	Perphenazine	Perphenazine	Sandoz	Rising Pharms
3/1/2019	Crestor	Rosuvastatin Calcium	IPR	Zydus
3/1/2019	Gleevec	Imatinib Mesylate	Novartis	Natco Pharma
3/1/2019	Protonix	Pantoprazole Sodium	Wyeth	Ingenus Pharms
3/4/2019	Micardis HCT	Telmisartan / Hydrochlorothiazide	Boehringer Ingelheim	Glenmark
3/4/2019	Exelon	Rivastigmine	Novartis	Zydus
3/4/2019	Faslodex	Fulvestrant	AstraZeneca	Amneal
3/5/2019	Epivir	Lamivudine	ViiV Healthcare	Mylan
3/5/2019	Bepreve	Bepotastine Besilate	Bausch and Lomb	Apotex
3/5/2019	Nexium 24Hr	Esomeprazole Magnesium	AstraZeneca	Actavis
3/5/2019	Kapvay	Clonidine HCl	Concordia Pharms	Novast Labs
3/6/2019	Lipitor	Atorvastatin Calcium	Pfizer	Lupin
3/8/2019	Tenoretic	Atenolol and Chlorthalidone	Alvogen Malta	Zydus
3/8/2019	Mestinon	Pyridostigmine Bromide	Bausch	Novitium Pharma
3/11/2019	Integrilin	Eptifibatide	Schering	USV
3/11/2019	Micro-K / Micro-K 10	Potassium Chloride	Nesher Pharms	Zydus
3/11/2019	Ampyra	Dalfampridine	Acorda	Micro Labs
3/12/2019	Diovan	Valsartan	Novartis	Alkem
3/12/2019	Claritin	Loratadine	Bayer Healthcare	Newgen Pharms
3/12/2019	Zanaflex	Tizanidine HCl	Covis Pharma	RiconPharma
3/12/2019	Procardia XL	Nifedipine	Pfizer	Novast Labs
3/12/2019	Zyloprim	Allopurinol	Casper Pharma	Unichem Labs
3/12/2019	Desonide	Desonide	Perrigo	Teligent Pharma
3/13/2019	Yasmin	Kemeya	Bayer Healthcare	Sun Pharm
3/13/2019	Sodium Chloride 3% in Plastic Container	Sodium Chloride 3% in Plastic Container	Baxter Healthcare	Fresenius Kabi
3/13/2019	Children's Zyrtec	Cetirizine HCl	J and J Consumer	Hetero Labs Ltd III
3/14/2019	Integrilin	Epifibatide	Schering	USV
3/14/2019	Lovenox	Enoxaparin Sodium	Sanofi Aventis	Amphastar
3/15/2019	Diovan HCT	Valsartan / Hydrochlorothiazide	Novartis	Zydus
3/15/2019	Zovirax	Acyclovir	Bausch	Zydua
3/18/2019	Bepreve	Bepotastine Besilate	Bausch and Lomb	Micro Labs
3/18/2019	Lidex	Fluocinonide	County Line Pharms	Teligent Pharma
3/19/2019	Invanz	Ertapenem Sodium	Merck Sharp Dohme	Savior Lifetec
3/19/2019	Latuda	Lurasidone HCl	Sunovion	Zydus
3/20/2019	Aggrenox	Aspirin / Dipyridamole	Boehringer Ingelheim	Lannett
3/20/2019	Naftin	Naftifine HCl	Sebela	Tolmar
3/21/2019	Epivir-HBV	Lamivudine	GlaxoSmithKline	Annora
3/22/2019	Tekturna	Aliskiren Hemifumarate	Noden Pharma	Anchen Pharms
3/22/2019	Daliresp	Roflumilast	AstraZeneca	Micro Labs
3/22/2019	Makena Preservative Free	Hydroxyprogesterone Caproate	Amag Pharma	Slayback Pharma
3/22/2019	Yaz	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Hetero
3/22/2019	Viagra	Sildenafil Citrate	Pfizer	Lupin
3/25/2019	Viagra	Sildenafil Citrate	Pfizer	Mylan
3/25/2019	Nuvigil	Armodafinil	Cephalon	Apotex
3/26/2019	Baraclude	Entecavir	Bristol-Myers Squibb	Mylan
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Alembic
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Aurobindo
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Zydus
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Sun Pharm
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Accord Healthcare
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Unichem Labs
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Cipla
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Ajanta
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Amneal
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Hetero
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Dr Reddy's Labs
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Qilu Pharm
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Lupin
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Sunshine Lake
3/26/2019	Cialis	Tadalafil	Eli Lilly and Co	Torrent
3/26/2019	Adcirca	Tadalafil	Eli Lilly and Co	Torrent
3/26/2019	Zanaflex	Tizanidine HCl	Covis Pharma	Cadila
3/27/2019	Zanaflex	Tizanidine HCl	Covis Pharma	Alkem Labs
3/28/2019	Letairis	Ambrisentan	Gilead	Watson
3/28/2019	Letairis	Ambrisentan	Gilead	Mylan
3/28/2019	Letairis	Ambrisentan	Gilead	Zydus
3/28/2019	Letairis	Ambrisentan	Gilead	Sun Pharm
3/28/2019	Xyzal Allergy 24Hr	Levocetirizine Dihydrochloride	Sanofi Avenits	Perrigo
3/29/2019	Cialis	Tadalafil	Eli Lilly and Co	Watson
3/29/2019	Azilect	Rasagiline Mesylate	Teva	Micro Labs
3/29/2019	Potassium Chloride	Potassium Chloride	Genus Lifesciences	Pharm Assoc