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

November 2019

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
07/01/2019	Hygroton	chlorthalidone	Sanofi Aventis	Amneal
07/01/2019	Uloric	febuxostat	Takeda	Mylan
07/01/2019	Uloric	febuxostat	Takeda	Alembic
07/01/2019	Uloric	febuxostat	Takeda	Sun Pharm
07/01/2019	Haldol	haloperidol	Janssen	Fresenius Kabi USA
07/01/2019	Omidria	ketorolac tromethamine / phenylephrine HCl	Omeros	Lupin
07/02/2019	Hemabate	carboprost tromethamine	Pharmacia and Upjohn	Dr Reddys
07/02/2019	Ery-Tab	erythromycin	Arbor	Amneal
07/02/2019	Sporanox	itraconazole	Johnson & Johnson	Pii
07/02/2019	MetroGel-Vaginal Gel	metronidazole	Bausch	Perrigo
07/02/2019	Cytotec	misoprostol	Pfizer	Zydus
07/02/2019	Ultram	tramadol HCl	Johnson & Johnson	Polygen Pharms
07/03/2019	Syprine	trientine HCl	Aton	Dr Reddys
07/05/2019	Trilipix	fenofibric acid	Abbvie	TWi
07/05/2019	Fluoxetine HCl	fluoxetine HCl	Alvogen	G and W Labs
07/05/2019	Ranexa	ranolazine	Gilead	Glenmark Pharms
07/08/2019	Effexor XR	venlafaxine HCl	Pfizer	Annora Pharma
07/09/2019	Atelvia	risedronate sodium	Allergan	Sun Pharm
07/10/2019	Zytiga	abiraterone acetate	Johnson & Johnson	MSN Labs
07/10/2019	Onfi	clobazam	Lundbeck	Vistapharm
07/10/2019	Neoral	cyclosporine	Novartis	Apotex
07/10/2019	Lovaza	omega-3-acid ethyl esters	Glaxo	Sofgen Pharms
07/12/2019	Cubicin	daptomycin	Cubist	Accord Healthcare
07/12/2019	Edecrin	ethacrynic acid	Bausch	Agnitio
07/12/2019	Lymphazurin	isosulfan blue	Mylan	Somerset Theraps
07/12/2019	Technescan Mag3	technetium tc 99m mertiatide kit	Curium	Pharmalucence
07/15/2019	Firazyr	icatibant acetate	Shire	Teva
07/15/2019	Concerta	methylphenidate HCl	Johnson & Johnson	Par
07/16/2019	Cosmegen	dactinomycin	Recordati	Hisun Pharm Hangzhou
07/17/2019	Adderall XR	dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate	Shire	Nesher Pharms
07/17/2019	Cyklokapron	tranexamic acid	Pharmacia and Upjohn	Caplin
07/17/2019	Cyklokapron	tranexamic acid	Pharmacia and Upjohn	Apollo Pharms
07/18/2019	Trilipix	fenofibric acid	Abbvie	Graviti Pharms
07/18/2019	Benicar	olmesartan medoxomil	Daiichi Sankyo	Umedica Labs
07/19/2019	Focalin	dexmethylphenidate HCl	Novartis	Alkem
07/19/2019	Lyrica	pregabalin	Pfizer	Teva
07/19/2019	Lyrica	pregabalin	Pfizer	Teva
07/19/2019	Lyrica	pregabalin	Pfizer	Alembic Pharms
07/19/2019	Lyrica	pregabalin	Pfizer	Alkem
07/19/2019	Lyrica	pregabalin	Pfizer	Alkem
07/19/2019	Lyrica	pregabalin	Pfizer	Sciegen Pharms
07/19/2019	Lyrica	pregabalin	Pfizer	MSN Labs
07/19/2019	Lyrica	pregabalin	Pfizer	Dr Reddys
07/19/2019	Lyrica	pregabalin	Pfizer	Amneal
07/19/2019	Lyrica	pregabalin	Pfizer	Rising
07/19/2019	Lyrica	pregabalin	Pfizer	Cipla
07/22/2019	Fanapt	iloperidone	Vanda	Taro Pharm
07/22/2019	Morphine Sulfate	morphine sulfate	Hikma	Upsher Smith Labs
07/22/2019	Rozarem	ramelteon	Takeda	Zydus
07/23/2019	Faslodex	fulvestrant	Astra-Zeneca	Mylan
07/23/2019	Yaz	kyra	Bayer	Sun Pharm
07/24/2019	Mycostatin	nystatin	Delcor Asset Corp	Torrent
07/25/2019	Lotrimin	clotrimazole	Schering Plough	Tasman Pharma
07/25/2019	Trilipix	fenofibric acid	Abbvie	Aurobindo
07/26/2019	Truvada	emtricitabine / tenofovir disoproxil fumarate	Gilead	Laurus Labs
07/26/2019	Nicorette	nicotine polacrilex	Glaxo	Teva
07/29/2019	Zosyn	piperacillin / tazobactam	Astral	Astral
07/30/2019	Gablofen	baclofen	Piramal	Maia Pharms
07/30/2019	Solodyn ER	minocycline HCl	Bausch	Mylan Labs
07/30/2019	Norcuron	vecuronium bromide	Organon	Hikma
07/31/2019	Colcrys	colchicine	Takeda	Teva
08/01/2019	Hiprex	methenamine hippurate	US Pharma	Micro Labs
08/01/2019	Visken	pindolol	Novartis	Bayshore Pharms
08/01/2019	Tasmar	tolcapone	Bausch	Kinedexe
08/02/2019	Sporanox	itraconazole	Johnson & Johnson	Apotex
08/02/2019	Patanol	olopatadine HCl	Novartis	Gland Pharma
08/02/2019	Quelicin	succinylcholine chloride	Hospira	Dr Reddys
08/05/2019	Evekeo	amphetamine sulfate	Arbor	Granules Pharms
08/05/2019	Depakene	valproic acid	Abbvie	Novelgenix Theraps
08/05/2019	Navelbine	vinorelbine tartrate	Pierre Fabre Medicament	Ingenus Pharms
08/06/2019	Hygroton	chlorthalidone	Sanofi-Aventis	Unichem Labs
08/07/2019	Celebrex	celecoxib	Searle	Qingdao Baheal Pharm
08/07/2019	Lovaza	omega-3-acid ethyl esters	Glaxo	Bionpharma
08/08/2019	Aromasin	exemestane	Pharmacia and Upjohn	Mayne Pharma
08/08/2019	Makeena	hydroxyprogesterone caproate	Amag	Aspen
08/08/2019	Reclast	zoledronic acid	Novartis	Gland Pharma
08/09/2019	Trusopt	dorzolamide HCl	Merck	Alembic
08/09/2019	Tricor	fenofibrate	Abbvie	Alembic
08/09/2019	Makeena	hydroxyprogesterone caproate	Amag	Am Regent
08/09/2019	Keppra	levetiracetam	UCB	Micro Labs
08/09/2019	Ultram	tramadol HCl	J&J	Unichem Labs
08/12/2019	Halog	halcinonide	Sun	Mylan
08/12/2019	Combivir	lamivudine / zidovudine	Glaxo	Mylan
08/13/2019	Toviaz	fesoterodine fumarate	Pfizer	Dr Reddys
08/13/2019	Salagen	pilocarpine HCl	Eisai	Aurobindo
08/13/2019	Zemuron	rocuronium bromide	Organon	Camargo Pharm
08/14/2019	Brevibloc	esmolol hydrochloride	Baxter	Gland Pharma
08/14/2019	Carnitor	levocarnitine	Leadiant Biosciences	Novitium Pharma
08/14/2019	Carnitor SF	levocarnitine sugar free	Leadiant Biosciences	Novitium Pharma
08/15/2019	Westcort	hydrocortisone valerate	Sun	Lupin
08/15/2019	Percocet	oxycodone / acetaminophen	Vintage Pharma	Halo Pharm
08/16/2019	Cymbalta	duloxetine HCl	Eli Lilly	Yaopharma
08/16/2019	Fusilev	levoleucovorin calcium	Spectrum	Nanjing King-Friend
08/16/2019	Merrem	meropenem	Astra-Zeneca	HQ Specialty Pharma
08/16/2019	Torisel	temsirolimus	Pfizer	Gland Pharma
08/19/2019	Acanya	clindamycin phosphate / benzoyl peroxide	Bausch	Taro
08/19/2019	Acanya	clindamycin phosphate / benzoyl peroxide	Bausch	Tolmar
08/19/2019	Proamatine	midodrine HCl	Shire	Rubicon
08/19/2019	Protonix IV	pantoprazole sodium	Wyeth	Sun Pharm
08/19/2019	Ranexa	ranolazine	Gilead	Zydus
08/19/2019	Zioptan	tafluprost	Santen	Micro Labs
08/19/2019	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn	Inventia Healthcare
08/19/2019	Dyrenium	triamterene	Concordia	Agnitio
08/20/2019	Kuvan Powder	sapropterin dihydrochloride	Biomarin	Par
08/20/2019	Kuvan Tablet	sapropterin dihydrochloride	Biomarin	Par
08/21/2019	Solodyn ER	minocycline HCl	Bausch	Aurobindo
08/21/2019	Solodyn ER	minocycline HCl	Bausch	Mylan
08/21/2019	Noxafil	posaconazole	Merck	Sinotherapeutics
08/22/2019	Cubicin	daptomycin	Cubist	Jiangsu Hengrui Med
08/22/2019	Faslodex	fulvestrant	Astra-Zeneca	Sagent
08/22/2019	Faslodex	fulvestrant	Astra-Zeneca	Glenmark
08/22/2019	Fusilev	levoleucovorin calcium	Spectrum	Nanjing King-Friend
08/22/2019	Methadose	methadone HCl	SPECGX	Pharm Assoc
08/22/2019	Aleve PM	naproxen sodium / diphenhydramine HCl	Bayer	Apotex
08/23/2019	Amicar	aminocaproic acid	Clover	Amneal
08/23/2019	Finacea	azelaic acid	Leo	Taro
08/23/2019	Astepro	azelastine HCl	Mylan	Hi Tech (Akorn)
08/26/2019	Orfadin	nitisinone	Sobi	Novitium Pharma
08/27/2019	Edecrin	ethacrynic acid	Bausch	Sciegen Pharms
08/27/2019	Vesicare	solifenacin succinate	Astellas	Unichem Labs
08/28/2019	Dacogen	decitabine	Otsuka	MSN Labs
08/29/2019	Elidel	pimecrolimus	Bausch	Glenmark
08/29/2019	Effexor XR	venlafaxine HCl	Pfizer	Cadila Pharms
08/30/2019	Relafen	nabumetone	SKB	Nexgen Pharma
08/30/2019	Aleve	naproxen sodium	Bayer	Yichang Humanwell
08/30/2019	Folxin OTIC	ofloxacin	Daiichi Sankyo	Amneal
08/30/2019	Zantac 150	ranitidine HCl	Sanofi Aventis	Unique Pharm Labs
08/30/2019	Zantac 75	ranitidine HCl	Sanofi Aventis	Unique Pharm Labs
09/03/2019	Xalatan	latanoprost	Pharmacia and Upjohn	Aurobindo
09/03/2019	Concerta	methylphenidate HCl	Johnson & Johnson	Ascent Pharms
09/04/2019	Latuda	lurasidone HCl	Sunovion	Emcure Pharms
09/05/2019	Wellbutrin XL	bupropion HCl	Valeant	Zhejiang Jutai Pharma
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Mylan
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Apotex
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	MSN Labs
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Lupin
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Sungen Pharma
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Baxter Healthcare
09/05/2019	Emend I.V.	fosaprepitant dimeglumine	Merck	Be Pharms
09/06/2019	Zovirax	acyclovir	Bausch Health	Apotex
09/06/2019	Proventil	albuterol sulfate	Schering	Quagen
09/06/2019	Onfi	clobazam	Lundbeck	Alkem
09/06/2019	Colcrys	colchicine	Takeda	Dr Reddys
09/06/2019	Edecrin	ethacrynic acid	Bausch	Lupin
09/06/2019	Tricor	fenofibrate	Abbvie	Appco Pharma
09/06/2019	Nicorette	nicotine polacrilex	Glaxo	P and L Dev
09/09/2019	Kyprolis	carfilzomib	Onyx	Dr Reddys
09/09/2019	Acanya	clindamycin phosphate / benzoyl peroxide	Bausch	Perrigo
09/09/2019	Olux-E foam	clobetasol propionate	Mylan	Glenmark
09/10/2019	Tylenol w/ Codeine	acetaminophen / codeine phosphate	Janssen	Elite Labs
09/11/2019	Lioresal	baclofen	Saol Therapeutics	Maia Pharms
09/12/2019	Parafon Forte	chlorzoxazone	Janssen	Novitium Pharma
09/13/2019	Sinequan	doxepin HCl	Pfizer	Ajanta
09/13/2019	Soolantra	ivermectin	Galderma	Teva
09/13/2019	Alkeran	melphalan hydrochloride	Apotex	Noratech Pharma
09/13/2019	Corgard	nadolol	US Worldmeds	Vgyaan Pharma
09/16/2019	Lotronex	alosetron HCl	Sebela	Eywa Pharma
09/16/2019	Colcrys	colchicine	Takeda	Mylan
09/16/2019	Dacogen	decitabine	Otsuka	Ingenus Pharms
09/16/2019	Syprine	trientine HCl	Aton	Kadmon Pharms
09/17/2019	Benicar	olmesartan medoxomil	Daiichi Sankyo	Micro Labs
09/17/2019	Benicar HCT	olmesartan medoxomil / hydrochlorothiazide	Daiichi Sankyo	Umedica Labs
09/20/2019	Lyrica	pregabalin	Pfizer	Mylan
09/20/2019	Zomig-ZMT	zolmitriptan	Astra-Zeneca	Mylan
09/23/2019	Invega	paliperidone	Janssen	Amneal
09/23/2019	Androgel 1.62%	testosterone	Unimed	Twi
09/24/2019	Clobex	clobetasol propionate	Galderma	Zydus
09/24/2019	Remodulin	treprostinil	United Therapeutics	Par
09/25/2019	Baraclude	entecavir	Bristol Myers Squibb	Brightgene Bio-Medical Tech
09/25/2019	Syprine	trientine HCl	Aton	Par
09/26/2019	Hectorol	doxercalciferol	Genzyme	Gland Pharma
09/26/2019	Patanol	olopatadine HCl	Novartis	FDC
09/26/2019	Prilosec	omeprazole	Astra-Zeneca	Hetero Labs
09/26/2019	Vesicare	solifenacin succinate	Astellas	Strides Pharma
09/26/2019	Remodulin	treprostinil	United Therapeutics	Teva
09/27/2019	Zytiga	abiraterone acetate	Johnson & Johnson	Qilu Pharm
09/27/2019	Tikosyn	dofetilide	Pfizer	Wilshire Pharms
09/30/2019	Dilantin	extended phenytoin sodium	Parke-Davis	Lupin
09/30/2019	Robinul	glycopyrrolate	Hikma	Gland Pharma
09/30/2019	Potassium Chloride	potassium chloride	Merck	Yichang Humanwell
09/30/2019	Lyrica	pregabalin	Pfizer	Hainan Shuangcheng Pharma
09/30/2019	Lyrica	pregabalin	Pfizer	Alkem
09/30/2019	Viibryd	vilazodone HCl	Allergan	Teva