ANDA Approvals

Spring 2018

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
1/8/2018	Xenazine	Tetrabenazine	Valeant Pharms	Dr Reddys
1/9/2018	Tamiflu	Oseltamivir Phosphate	Roche	Lupin
1/12/2018	K-Tab	Potassium Chloride	AbbVie	Paddock
1/16/2018	Ultiva	Remifentanil HCl	Mylan	Fresenius Kabi
1/17/2018	Dilaudid	Hydromorphone HCl	Rhodes Pharms	Ascent Pharms
1/19/2018	Taxotere	Docetaxel	Accord Healthcare / Sanofi Aventis	Amneal
1/19/2018	Xyzal Allergy 24HR (OTC)	Levocetirizine Dihydrochloride (OTC)	Sanofi-Aventis	Dr Reddys
1/23/2018	Epiduo	Adapalene / Benzoyl Peroxide	Galderma Labs	Perrigo
1/23/2018	Bumex	Bumetanide	Validus Pharms	Upsher-Smith Labs
1/23/2018	Celebrex	Celecoxib	GD Searle	CSPC Ouyi Pharm
1/24/2018	Epiduo	Adapalene / Benzoyl Peroxide	Galderma Labs	Taro
1/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Cipla
1/26/2018	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Aurobindo
1/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Hetero Labs
1/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Aurobindo
1/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Strides
1/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	MacLeods
1/26/2018	Argatroban	Argatroban	Novartis	Amneal
1/26/2018	Feldene	Piroxicam	Pfizer	Strides
1/29/2018	Kapvay	Clonidine HCl	Concordia Pharms	Jubilant Generics
2/1/2018	Concerta	Methylphenidate HCl	Janssen	Amneal
2/1/2018	Niaspan	Niacin	AbbVie	Aurobindo
2/2/2018	Effient	Prasugrel	Eli Lilly	Accord Healthcare
2/2/2018	Opana	Oxymorphone HCl	Endo	Ascent Pharms
2/6/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Novast Labs
2/7/2018	Syprine	Trientine HCl	Aton	Watson
2/8/2018	Cleocin T	Clindamycin Phosphate	Pharmacia and Upjohn	Glasshouse Pharms
2/9/2018	Tricor	Fenofibrate	AbbVie	Amneal
2/9/2018	Namenda	Memantine HCl	Allergan	Apotex
2/12/2018	Copaxone	Glatopa	Teva	Sandoz
2/13/2018	Cardura	Doxazosin Mesylate	Pfizer	Heritage Pharma
2/13/2018	Diprolene	Betamethasone Dipropionate	Merck Sharp Dohme	Teligent Pharma
2/15/2018	Treximet	Sumatriptan / Naproxen Sodium	Pernix Ireland	Aurobindo
2/16/2018	Adenocard	Adenosine	Astellas	Gland Pharma
2/20/2018	Tamiflu	Oseltamivir Phosphate	Roche	Lupin
2/21/2018	Feldene	Piroxicam	Pfizer	Laboratorios Cinfa
2/22/2018	Zantac 150 (OTC)	Ranitidine HCl (OTC)	Sanofi	Vivimed Global
2/23/2018	Strattera	Atomoxetine HCl	Eli Lilly	Dr Reddys
2/23/2018	Lotronex	Alosetron HCl	Sebela Ireland	Par
2/23/2018	Tamiflu	Oseltamivir Phosphate	Roche	Hetero Labs
2/26/2018	Ritalin LA	Methylphenidate HCl	Novartis	Mayne Pharma
2/26/2018	Suprane	Desflurane	Baxter Healthcare	Shanghai Hengrui
2/26/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Laurus Labs
2/27/2018	Precedex	Dexmedetomidine HCl	Hospira	Zydus
2/27/2018	Yaz	Lo-Zumandimine	Bayer	Aurobindo
2/28/2018	Activella	Estradiol / Norethindrone Acetate	Amneal	Accord Healthcare
3/2/2018	Bystolic	Nebivolol HCl	Allergan	Torrent
3/2/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead	Qilu Tianhe
3/2/2018	Ritalin	Methylphenidate HCl	Novartis	Bionpharma
3/5/2018	Eloxatin	Oxaliplatin	Sanofi Aventis / Teva	Actavis
3/5/2018	Zantac 75 (OTC)	Ranitidine HCl (OTC)	Sanofi	Vivimed Global
3/5/2018	Urocit-K	Potassium Citrate	Mission Pharma	Teva
3/6/2018	Nuvigil	Armodafinil	Cephalon	Aurobindo
3/6/2018	Gablofen	Baclofen	Piramal	Mylan
3/7/2018	Integrilin	Eptifibatide	Schering	Sagent
3/7/2018	Zovirax	Acyclovir	Mylan	Yiling Pharm
3/8/2018	Sensipar	Cinacalcet HCl	Amgen	Aurobindo
3/8/2018	Sensipar	Cinacalcet HCl	Amgen	Cipla
3/9/2018	Zanaflex	Tizanidine HCl	Covis Pharma	Zydus
3/12/2018	Sustiva	Efavirenz	Bristol-Myers Squibb	Strides
3/13/2018	Sabril	Vigabatrin	Lundbeck	Amneal
3/14/2018	Ziagen	Abacavir Sulfate	ViiV Healthcare	Aurobindo
3/16/2018	Zegerid (OTC)	Omeprazole / Sodium Bicarbonate (OTC)	Bayer	Zydus
3/16/2018	Solodyn	Minocycline HCl	Medicis	Alkem Labs
3/16/2018	Naropin	Ropivacaine HCl	Fresenius Kabi	Akorn
3/16/2018	Dacogen	Decitabine	Otsuka	Sagent
3/16/2018	Topicort	Desoximetasone	Taro	Lupin
3/16/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Granules
3/19/2018	Cyclophosphamide	Cyclophosphamide	West-Ward Pharms	Amerigen Pharms
3/19/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Alignscience Pharma
3/20/2018	Renvela	Sevelamer Carbonate	Genzyme	Sandoz
3/20/2018	Keppra	Levetiracetam	UCB	Hainan Poly Pharm
3/20/2018	Ultravate	Halobetasol Propionate	Sun Pharm Inds	Teligent Pharma
3/21/2018	Concerta	Methylphenidate HCl	Janssen	Actavis
3/21/2018	Patanol	Olopatadine HCl	Novartis	Micro Labs
3/21/2018	Loestrin 24 FE	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Apil	Apotex
3/21/2018	Lioresal	Baclofen	Saol Theraps Res	Mylan
3/22/2018	Concerta	Methylphenidate HCl	Janssen	Actavis
3/23/2018	Aloxi	Palonosetron HCl	Helsinn Healthcare	Teva
3/23/2018	Lialda	Mesalamine	Shire	Actavis
3/23/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Zydus
3/26/2018	Tikosyn	Dofetilide	Pfizer	Sigmapharm Labs
3/26/2018	Clobex	Clobetasol Propionate	Galderma Labs	Lupin
3/26/2018	Clobex	Clobetasol Propionate	Galderma Labs	Taro
3/26/2018	Clobex	Clobetasol Propionate	Galderma Labs	Glenmark
3/26/2018	Yasmin	Zumandimine	Bayer	Aurobindo
3/28/2018	Advil Liqui-Gels (OTC) / Advil Migraine Liqui-Gels (OTC)	Ibuprofen (OTC)	Pfizer	Strides
3/30/2018	Nimbex	Cisatracurium Besylate	AbbVie	Hospira
3/30/2018	Nimbex	Cisatracurium Besylate	AbbVie	Hospira
3/30/2018	Lipitor	Atorvastatin Calcium	Pfizer	Accord Healthcare
3/30/2018	Dolophine	Methadone HCl	West-Ward Pharms	Sun Pharm

GENERICally Speaking Spring 2018

Oren D. Langer

Partner

Managing Partner, New York Office

Jeffrey Alan Hovden

Partner