ANDA Approvals

Winter 2016

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/6/2016	Morphine Sulfate	Morphine Sulfate	Roxane	Nostrum Labs
10/6/2016	Virazole	Ribavirin	Valeant	Navinta
10/7/2016	Motrin IB (OTC)	Ibuprofen (OTC)	Johnson and Johnson Consumer	Granules India Ltd
10/7/2016	Abilify	Aripiprazole	Otsuka	MacLeods
10/7/2016	Paricalcitol	Paricalcitol	Teva	Marksans Pharma
10/11/2016	Safyral	Drospirenone / Ethinyl Estradiol / Levomefolate Calcium	Bayer Healthcare	Watson Labs
10/12/2016	Avalide	Irbesartan / Hydrochlorothiazide	Sanofi Aventis US	Alembic Pharms
10/12/2016	Enablex	Darifenacin Hydrobromide	Apil	Jubilant Generics
10/12/2016	Namenda XR	Memantine Hydrochloride	Forest Labs	Amneal
10/12/2016	Evista	Raloxifene Hydrochloride	Eli Lilly	Sciegen Pharms
10/14/2016	Prevacid	Lansoprazole	Takeda	Ajanta Pharma
10/14/2016	Avalide	Irbesartan / Hydrochlorothiazide	Sanofi Aventis US	Hisun Pharm Hangzhou
10/17/2016	Precedex	Dexmedetomidine Hydrochloride	Hospira	Actavis
10/17/2016	Perphenazine	Perphenazine	Sandoz	Watson Labs
10/21/2016	Avodart	Dutasteride	GlaxoSmithKline	Ascent Pharms
10/21/2016	Concerta	Methylphenidate Hydrochloride	Janssen	Mylan
10/21/2016	Actonel	Risedronate Sodium	Apil	Aurobindo Pharma
10/21/2016	Sarafem	Fluoxetine Hydrochloride	Apil	Torrent
10/21/2016	Ortho-Novum 7/7/7-28	norethindrone / ethinyl estradiol	Janssen	Aurobindo Pharma
10/21/2016	Modicon 28	Norethindrone / ethinyl estradiol	Janssen	Aurobindo Pharma
10/21/2016	Ortho-Novum 1/35-28	norethindrone / ethinyl estradiol	Janssen	Aurobindo Pharma
10/21/2016	Betapace	Sotalol Hydrochloride	Covis Pharma	Beximco Pharms USA
10/21/2016	Dextrose 5% in Plastic Container	Dextrose 5% in Plastic Container	B Braun / Baxter Healthcare / Hospira	Fresenius Kabi USA
10/21/2016	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	Actavis
10/24/2016	Nystatin / Triamcinolone Acetonide	Nystatin / Triamcinolone Acetonide	Taro	Glenmark
10/26/2016	Benicar	Olmesartan Medoxomil	Daiichi Sankyo	Mylan
10/26/2016	Benicar HCT	Olmesartan Medoxomil / Hydrochlorothiazide	Daiichi Sankyo	Mylan
10/26/2016	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Teva
10/26/2016	Tribenzor	Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide	Daiichi Sankyo	Torrent
10/26/2016	Tribenzor	Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide	Daiichi Sankyo	Par
10/26/2016	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	MacLeods Pharms
10/26/2016	Nystatin and Triamcinolone Acetonide	Nystatin and Triamcinolone Acetonide	Taro	Dr Reddys
10/27/2016	Robaxin	Methocarbamol	West-Ward Pharms	Monterey Pharms
10/27/2016	Acetazolamide	Acetazolamide	Taro	Heritage Pharma
10/27/2016	Ortho Cyclen-28	Norgestimate / Ethinyl Estradiol	Janssen	Lupin
10/27/2016	Ipratropium Bromide	Ipratropium Bromide	Ritedose	Aurobindo Pharma
10/28/2016	Angiomax	Bivalirudin	The Medicines Co	Fresenius Kabi USA
10/28/2016	Ziagen	Abacavir Sulfate	VIIV Healthcare	Strides Pharma
10/28/2016	Cellcept	Mycophenolate Mofetil Hydrochloride	Roche Palo	Par
10/28/2016	Norpramin	Desipramine Hydrochloride	US Pharm	Corepharma
10/28/2016	MS Contin	Morphine Sulfate	Purdue Pharma	Mayne Pharma
10/28/2016	Butalbital / Acetaminophen / Caffeine	Butalbital / Acetaminophen / Caffeine	Nexgen Pharma	Nuvo Pharm
10/28/2016	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Ajanta Pharma
10/28/2016	Singulair	Montelukast Sodium	Merck	Cipla
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Torrent Pharms
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Accord Healthcare
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Jubilant Generics
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Changzhou Pharm
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Hetero Labs
10/31/2016	Crestor	Rosuvastatin Calcium	IPR	Biocon
11/1/2016	Ketorolac Tromethamine	Ketorolac Tromethamine	Hospira	Gland Pharma
11/3/2016	Tribenzor	Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide	Daiichi Sankyo	Teva
11/3/2016	Ibuprofen	Ibuprofen	Actavis	Hi-Tech Pharmacal
11/4/2016	Duragesic-25	Fentanyl-25	Janssen	3M Drug Delivery
11/4/2016	Ortho Tri-Cyclen Lo	norgestimate / ethinyl estradiol	Janssen	Aurobindo Pharma
11/7/2016	Zegerid (OTC)	Omeprazole / Sodium Bicarbonate	Bayer Healthcare	Aurolife Pharma
11/7/2016	Topicort	Desoximetasone	Taro	Actavis
11/7/2016	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Novel Labs	Tedor Pharma
11/8/2016	Optivar	Azelastine Hydrochloride	Meda Pharms	Akorn
11/9/2016	Phentermine Hydrochloride	Phentermine Hydrochloride	Sandoz	Aurolife Pharma
11/9/2016	Tylenol (OTC)	Acetaminophen	Johnson and Johnson Consumer	Aurobindo Pharma
11/9/2016	Solu-Medrol	Methylprednisolone Sodium Succinate	Pharmacia and Upjohn	Amneal
11/10/2016	Aricept ODT	Donepezil Hydrochloride	Eisai	Unichem Labs
11/10/2016	Aygestin	Norethindrone Acetate	Duramed Res	Jai Pharma
11/10/2016	Namenda	Memantine Hydrochloride	Forest Labs	Silarx Pharms
11/14/2016	Hydrocodone Bitartrate / Acetaminophen	Hydrocodone Bitartrate / Acetaminophen	Mikart	Novel Labs
11/14/2016	Morphine Sulfate	Morphine Sulfate	Roxane	Pharm Assoc
11/14/2016	Afirmelle	Levonorgestrel / Ethinyl Estradiol	Mayne Pharma	Aurobindo Pharma
11/15/2016	Butalbital / Acetaminophen	Butalbital / Acetaminophen	Nexgen Pharma	Mikart
11/15/2016	Doryx	Doxycycline Hyclate	Mayne Pharma	Prinston
11/16/2016	Flagyl	Metronidazole	GD Searle	Zydus
11/17/2016	Enablex	Darifenacin Hydrobromide	Apil	Torrent
11/17/2016	Twynsta	Telmisartan / Amlodipine	Boehringer Ingelheim	Alembic Pharms
11/17/2016	Pravachol	Pravastatin Sodium	Bristol Myers Squibb	Accord Healthcare
11/18/2016	Intermezzo	Zolpidem Tartrate	Purdue Pharma	Dr Reddys Labs
11/18/2016	Adipex-P	Phentermine Hydrochloride	Teva	Polygen Pharms
11/18/2016	Methylin	Methylphenidate Hydrochloride	Mallinckrodt	Abhai
11/21/2016	Epivir	Lamivudine	VIIV Healthcare	Aurobindo Pharma
11/21/2016	Epivir	Lamivudine	VIIV Healthcare	Aurobindo Pharma
11/21/2016	Epivir	Lamivudine	VIIV Healthcare	Appco Pharma
11/22/2016	Detrol LA	Tolterodine Tartrate	Pharmacia and Upjohn	Teva
11/22/2016	Skelaxin	Metaxalone	King Pharms	Lannett
11/22/2016	Namenda XR	Memantine Hydrochloride	Forest Labs	Apotex
11/22/2016	Yasmin	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Accord Healthcare
11/23/2016	Ibuprofen	Ibuprofen	Dr Reddys	Aiping Pharm
11/23/2016	Temodar	Temozolomide	Merck Sharp Dohme	Chemi Spa
11/23/2016	Baraclude	Entecavir	Bristol Myers Squibb	Par
11/23/2016	Entocort EC	Budesonide	Perrigo	Alvogen Malta
11/23/2016	Crestor	Rosuvastatin Calcium	IPR	Cadila Pharms
11/23/2016	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Vistapharm	Wes Pharma
11/25/2016	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Torrent
11/25/2016	Arthrotec	Diclofenac Sodium / Misoprostol	GD Searle	Amneal
11/25/2016	Toprol-XL	Metoprolol Succinate	AstraZeneca	Actavis
11/28/2016	Nuvigil	Armodafinil	Cephalon	Lupin
11/28/2016	Nuvigil	Armodafinil	Cephalon	Natco Pharma
11/28/2016	Zometa	Zoledronic Acid	Novartis	Accord Healthcare
11/28/2016	Fanapt	Iloperidone	Vanda Pharms	Inventia Healthcare
11/28/2016	Zinecard	Dexrazoxane Hydrochloride	Pharmacia and Upjohn	Gland Pharma
11/29/2016	Actonel	Risedronate Sodium	Apil	MacLeods Pharms
11/29/2016	Clozaril	Clozapine	Heritage Life	Aurobindo Pharma
11/29/2016	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Ivax Sub Teva Pharms	Appco Pharma
11/29/2016	Hydrocodone Bitartrate / Acetaminophen	Hydrocodone Bitartrate / Acetaminophen	Mikart	Amneal
11/29/2016	Clobex	Clobetasol Propionate	Galderma Labs	Teligent Pharma
11/30/2016	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Par
11/30/2016	Topicort	Desoximetasone	Taro	Groupe Parima
11/30/2016	Hycamtin	Topotecan Hydrochloride	Novartis	Ingenius Pharms
12/1/2016	Zomig-ZMT	Zolmitriptan	AstraZeneca	Alembic Pharms
12/1/2016	Norco	Hydrocodone Bitartrate / Acetaminophen	Apil	Novel Labs
12/1/2016	Dapsone	Dapsone	Jacobus	Par
12/1/2016	Topicort	Desoximetasone	Taro	Lupin
12/5/2016	Atacand	Candesartan Cilexetil	Astrazeneca	MacLeods Pharms
12/6/2016	Cytovene	Ganciclovir	Roche Palo	Par
12/6/2016	Baraclude	Entecavir	Bristol Myers Squibb	Cipla
12/6/2016	Zegerid	Omeprazole / Sodium Bicarbonate	Santarus	Sciegen Pharms
12/6/2016	Amantadine Hydrochloride	Amantadine Hydrochloride	Sandoz	Watson
12/7/2016	Elestat	Epinastine Hydrochloride	Allergan	Alcon
12/7/2016	Abilify	Aripiprazole	Otsuka	Accord Healthcare
12/7/2016	Glucophage XR	Metformin Hydrochloride	Bristol Myers Squibb	MacLeods Pharms
12/7/2016	Kenalog	Triamcinolone Acetonide	Ranbaxy Labs	Akorn
12/8/2016	Integrilin	Eptifibatide	Schering	Amneal
12/8/2016	Nitropress	Sodium Nitroprusside	Hospira	Namigen
12/12/2016	Xeloda	Capecitabine	Hoffmann La Roche	Shilpa Medicare
12/12/2016	Topicort	Desoximetasone	Taro	Lupin
12/13/2016	Sporanox	Itraconazole	Janssen	Par
12/13/2016	Sporanox	Itraconazole	Janssen	Alembic Pharms
12/13/2016	Nor-QD	Norethindrone	Apil	Accord Healthcare
12/13/2016	Glucophage XR	Metformin Hydrochloride	Bristol Myers Squibb	Beximco Pharms
12/13/2016	Percocet	Oxycodone / Acetaminophen	Vintage Pharms	Cerovene
12/15/2016	Nicorette (OTC)	Nicotine Polacrilex	GlaxoSmithKline	Perrigo
12/15/2016	Nicorette (OTC)	Nicotine Polacrilex	GlaxoSmithKline	Perrigo
12/15/2016	Amantadine Hydrochloride	Amantadine Hydrochloride	USL Pharma	Watson
12/15/2016	Tricor	Fenofibrate	Abbvie	Cipla
12/15/2016	Micardis HCT	Telmisartan / Hydrochlorothiazide	Boehringer Ingelheim	Aurobindo Pharma
12/16/2016	Elixophyllin	Theophylline	Nostrum Labs	Pharm Assoc
12/19/2016	Alkeran	Melphalan Hydrochloride	Apotex Inc	Actavis
12/20/2016	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharm Assoc	Edenbridge Pharms
12/20/2016	Xyzal	Levocetirizine Dihydrochloride	UCB Inc	Nostrum Labs
12/20/2016	Livalo	Pitavastatin Calcium	Kowa Co	Aurobindo Pharma
12/20/2016	Zyvox	Linezolid	Pharmacia and Upjohn	Nang Kuang Pharm
12/20/2016	Nystatin / Triamcinolone Acetonide	Nystatin / Triamcinolone Acetonide	Taro	Perrigo
12/21/2016	Zovirax	Acyclovir	Valeant Bermuda	Taro
12/22/2016	Cordran	Flurandrenolide	Aqua Pharms	Teligent Pharma
12/22/2016	Lotronex	Alosetron Hyrdochloride	Sebela Ireland	Amneal
12/23/2016	Topicort	Desoximetasone	Taro	G and W Labs
12/23/2016	Tretinoin	Tretinoin	Barr Labs	Glenmark Generics
12/27/2016	Geodon	Ziprasidone Hydrochloride	Pfizer	Aurobindo Pharma
12/27/2016	Indomethacin	Indomethacin	Sandoz	Aurobindo Pharma
12/27/2016	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Lyne	Patrin Pharma
12/27/2016	Norethindrone Acetate / Ethinyl Estradiol	Norethindrone Acetate / Ethinyl Estradiol	Barr Labs	Jai Pharma
12/27/2016	Kaletra	Lopinavir / Ritonavir	Abbvie	Silarx Pharms
12/29/2016	Glucotrol XL	Glipizide	Pfizer	Unique Pharm Labs
12/29/2016	Treanda	Bendamustine Hydrochloride	Cephalon	Breckenridge
12/29/2016	Nystatin / Triamcinolone Acetonide	Nystatin / Triamcinolone Acetonide	Taro	RiconPharma
12/29/2016	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Ivax Sub Teva Pharms	Apex Pharms
12/30/2016	Evoxac	Cevimeline Hydrochloride	Daiichi Sankyo	Novel Labs
12/30/2016	Augmentin '875'	Amoxicillin / Clavulanate Potassium	Dr Reddys Labs	Micro Labs
12/30/2016	Augmentin '250' / Augmentin '500'	Amoxicillin / Clavulanate Potassium	Dr Reddys Labs	Micro Labs
12/30/2016	Cleocin T	Clindamycin Phosphate	Pharmacia and Upjohn	Teligent Pharma
12/30/2016	Xopenex	Levalbuterol Hydrochloride	Oak Pharms	Aurobindo Pharma
12/30/2016	Cordran	Flurandrenolide	Aqua Pharms	Teligent Pharma
12/30/2016	Nystatin / Triamcinolone Acetonide	Nystatin / Triamcinolone Acetonide	Taro	Teligent Pharma

Amlodipine Besylate / Valsartan

GENERICally Speaking Winter 2016

Oren D. Langer

Partner

Managing Partner, New York Office

Miles A. Finn, Ph.D.

Counsel

Jeffrey Alan Hovden

Partner

Ryan M. Schultz