ANDA Approvals

Summer 2016

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
4/4/2016	Polymyxin B Sulfate	Polymyxin B Sulfate	Eurohealth Intl	Aurobindo Pharma
4/8/2016	Entocort EC	Budesonide	Perrigo	Actavis
4/8/2016	Evista	Raloxifene Hydrochloride	Eli Lilly	Amneal
4/11/2016	Fludeoxyglucose F18	Fludeoxyglucose F18	Queen Hamamatsu Pet	Kreitchman Pet Ctr
4/11/2016	Gemcitabine Hydrochloride	Gemcitabine Hydrochloride	Hospira	Actavis
4/12/2016	Kadian	Morphine Sulfate	Allergan	Impax Labs
4/12/2016	Norco	Hydrocodone Bitartrate / Acetaminophen	Watson Labs / Actavis	Rhodes Pharms
4/12/2016	Aricept	Donepezil Hydrochloride	Eisai	Indicus Pharma
4/12/2016	Merrem	Meropenem	AstraZeneca	Amneal
4/12/2016	Temodar	Temozolomide	Merck Sharp Dohme	IDT Australia
4/12/2016	Roxicodone	Oxycodone Hydrochloride	Mallinckrodt	Ken Lifescience
4/13/2016	Vfend	Voriconazole	PF Prism CV	Amneal
4/13/2016	Cordran SP	Flurandrenolide	Aqua Pharms	Teligent Pharma
4/14/2016	Zyfrel	Hydrocodone Bitartrate / Acetaminophen	Mikart	Cypress Pharm
4/14/2016	Glyburide	Glyburide	Teva	Pharmadax
4/14/2016	Polymyxin B Sulfate	Polymyxin B Sulfate	Eurohealth Intl	Gland Pharma
4/15/2016	Lexiva	Fosamprenavir Calcium	VIIV Healthcare	Mylan
4/15/2016	Surmontil	Trimipramine Maleate	Odyssey Pharms	Crossmedika
4/19/2016	Latisse	Bimatoprost	Allergan	Sandoz
4/19/2016	Indocin	Indomethacin Sodium	Recordati Rare	Hospira
4/19/2016	Merrem	Meropenem	AstraZeneca	Savior Lifetec
4/20/2016	Cytomel	Liothyronine Sodium	King Pharms	Sun Pharm
4/21/2016	Aloxi	Palonosetron Hydrochloride	Helsinn Healthcare	Dr. Reddys Labs
4/21/2016	Mirapex ER	Pramipexole Dihydrochloride	Boehringer Ingelheim	Actavis
4/21/2016	Nexium	Esomeprazole Magnesium	AstraZeneca	Aurobindo Pharma
4/22/2016	Xalatan	Latanoprost	Pharmacia and Upjohn	FDC
4/22/2016	Savella	Milnacipran Hydrochloride	Cypress Bioscience	Amneal
4/22/2016	Micardis	Telmisartan	Boehringer Ingelheim	Hetero Labs
4/25/2016	Derma-Smoothe/FS	Fluocinolone Acetonide	Hill Dermac	Lyne
4/25/2016	Derma-Smoothe/FS	Fluocinolone Acetonide	Hill Dermac	Lyne
4/25/2016	Dermotic	Fluocinolone Acetonide	Hill Dermac	Lyne
4/25/2016	Exforge	Amlodipine Besylate / Valsartan	Novartis	Aurobindo Pharma
4/26/2016	Opana	Oxymorphone Hydrochloride	Endo Pharms	Aurolife Pharma
4/26/2016	Ortho Tri-Cyclen	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Lupin
4/26/2016	Pepcid AC (OTC)	Famotidine (OTC)	Johnson and Johnson	Aurobindo Pharma
4/26/2016	Cortef	Hydrocortisone	Pharmacia and Upjohn	Pharmaceutics Intl
4/27/2016	Temodar	Temozolomide	Merck Sharp Dohme	Lotus Pharm
4/28/2016	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Akorn	Mylan
4/28/2016	Vimpat	Lacosamide	UCB	Amneal
4/28/2016	Vimpat	Lacosamide	UCB	Actavis
4/28/2016	Vimpat	Lacosamide	UCB	MSN Labs PVT
4/28/2016	Vimpat	Lacosamide	UCB	Alembic Pharms
4/28/2016	Vimpat	Lacosamide	UCB	Aurobindo Pharma
4/28/2016	Vimpat	Lacosamide	UCB	Mylan
4/28/2016	Vimpat	Lacosamide	UCB	Sun Pharma
4/28/2016	Solaraze	Diclofenac Sodium	Fougera Pharms	Taro
4/29/2916	Crestor	Rosuvastatin Calcium	IPR	Watson Labs
4/29/2016	Glucophage XR	Metformin Hydrochloride	Bristol Myers Squibb	Marksans Pharma
4/29/2016	Roxicodone	Oxycodone Hydrochloride	Mallinckrodt	Coastal Pharms
4/29/2016	Rythmol SR	Propafenone Hydrochloride	GlaxoSmithKline	Mylan
4/29/2016	Vidaza	Azacitidine	Celgene	Mylan
5/2/2016	Cambia	Diclofenac Potassium	Depomed	Par
5/3/2016	Lioresal	Baclofen	Saol Theraps Res	Sintetica
5/3/2016	Camptosar	Irinotecan Hydrochloride	Pfizer	Qilu Pharm Co
5/3/2016	Furadantin	Nitrofurantoin	Shionogi	Actavis
5/5/2016	Tricor	Fenofibrate	Abbvie	Aurobindo Pharma
5/5/2016	Norpramin	Desipramine Hydrochloride	US Pharm Holdings	Indicus Pharma
5/6/2016	Natazia	Estradiol Valerate / Dienogest	Bayer Healthcare	Watson Labs
5/6/2016	Dapsone	Dapsone	Jacobus	Nostrum Labs
5/6/2016	Buphenyl	Sodium Phenylbutyrate	Horizon Pharma	Par
5/10/2016	Dapsone	Dapsone	Jacobus	North Creek Pharms
5/10/2016	Nicorette (OTC)	Nicotine Polacrilex (OTC)	GlaxoSmithKline	Actavis
5/10/2016	Glyburide	Glyburide	Teva	Zydus Pharms USA
5/10/2016	Topicort	Desoximetasone	Taro	Novel Labs
5/11/2016	Rythmol	Propafenone Hydrochloride	GlaxoSmithKline	Orion Corp Orion
5/11/2016	Oxaliplatin	Oxaliplatin	Sun Pharma	Qilu Pharm Co
5/11/2016	Zovirax	Acyclovir	Valeant Bermuda	Fougera Pharms
5/11/2016	Zomig	Zolmitriptan	IPR	Aurbindo Pharma
5/12/2016	Ortho Tri-Cyclen Lo	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Haupt Pharma
5/13/2016	Triamcinolone Acetonide	Triamcinolone Acetonide	Perrigo	Teligent Pharma
5/13/2016	Dilaudid	Hydromorphone Hydrochloride	Purdue Pharm	Aurolife Pharma
5/13/2016	Marcaine	Bupivacaine Hydrochloride	Hospira	Aurobindo Pharma
5/16/2016	Banzel	Rufinamide	Eisai	Roxane
5/16/2016	Banzel	Rufinamide	Eisai	Glenmark Pharms
5/16/2016	Banzel	Rufinamide	Eisai	Mylan
5/16/2016	Flagyl	Metronidazole	GD Searle	Flamingo Pharms
5/17/2016	Seroquel	Quetiapine Fumarate	AstraZeneca	Macleods Pharms
5/18/2016	Bacteriostatic Sodium Chloride 0.9% in Plastic Container / Sodium Chloride 0.9% Plastic Container	Bacteriostatic Sodium Chloride 0.9% in Plastic Container / Sodium Chloride 0.9% Plastic Container	Hospira / Baxter Healthcare / Fresenius Kabi USA / Taro Pharms Ireland	Jubilant Hollistrstr
5/19/2016	Derma-Smoothe/FS	Fluocinolone Acetonide	Hill Dermac	Taro
5/19/2016	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Kreitchman Pet Ctr
5/19/2016	Lipitor	Atorvastatin Calcium	Pfizer	Sciegen Pharms
5/19/2016	Treanda	Bendamustine Hydrochloride	Cephalon	Accord Healthcare
5/19/2016	Derma-Smoothe/FS	Fluocinolone Acetonide	Hill Dermac	Taro Pharm Inds
5/20/2016	Zomig	Zolmitriptan	IPR	Ajanta Pharma
5/20/2016	Treanda	Bendamustine Hydrochloride	Cephalon	Hospira
5/23/2016	Restoril	Temazepam	Mallinckrodt	Amneal Pharms
5/24/2016	Vfend	Voriconazole	PF Prism CV	Ajanta Pharma
5/24/2016	Minastrin 24 FE	norethindrone acetate / ethinyl estradiol / ferrous fumarate	Apil	Lupin
5/24/2016	Vfend	Voriconazole	PF Prism CV	Zydus Pharms USA
5/24/2016	Vfend	Voriconazole	PF Prism CV	Appco Pharma
5/24/2016	Vfend	Voriconazole	PF Prism CV	Novel Labs
5/26/2016	Cleocin	Clindamycin Palmitate Hydrochloride	Pharmacia and Upjohn	Mylan
5/27/2016	Robaxin	Methocarbamol	Eurohealth Intl	Aurbindo Pharma
5/31/2016	Lo Loestrin FE	Norethindrone Acetate / Ethinyl Estradiol / Ethinyl Estradiol / Ferrous Fumarate	Apil	Jai Pharma
5/31/2016	Vfend	Voriconazole	PF Prism CV	Novel Labs
5/31/2016	Amantadine Hydrochloride	Amantadine Hydrochloride	Sandoz	Zydus Pharms USA
6/1/2016	Prevacid 24 Hr (OTC)	Lansoprazole (OTC)	Novartis	Mylan
6/2/2016	Vicoprofen	Hydrocodone Bitartrate / Ibuprofen	Abbvie	Aurolife Pharma
6/2/2016	Hydrocodone Bitartrate / Acetaminophen	Hydrocodone Bitartrate / Acetaminophen	Mikart	Actavis
6/2/2016	Keppra	Levetiracetam	UCB	Jubilant Life
6/3/2016	Leribane	Norethindrone Acetate / Ethinyl Estradiol	Barr Labs	Novast Labs
6/3/2016	Femara	Letrozole	Novartis	Hikma Pharms
6/3/2016	Cordarone	Amiodarone Hydrochloride	Wyeth	Aurobindo Pharma
6/6/2016	Keppra XR	Levetiracetam	UCB	Lotus Pharm Co
6/6/2016	Tikosyn	Dofetilide	Pfizer	Tiger Pharms
6/7/2016	Eloxatin	Oxaliplatin	Sanofi Aventis US / Teva	Qilu Pharm Co
6/8/2016	Merrem	Meropenem	AstraZeneca	Gland Pharma
6/9/2016	Zantac	Ranitidine Hydrochloride	IGI Labs	Mylan
6/9/2016	Merrem	Meropenem	AstraZeneca	Par
6/9/2016	Emend	Fosaprepitant Dimeglumine	Merck	Fresenius Kabi USA
6/9/2016	Cyklokapron	Tranexamic Acid	Pharmacia and Upjohn	Akorn
6/10/2016	Sprycel	Dasatinib	Bristol Myers Squibb	Apotex
6/10/2016	Neomycin Sulfate	Neomycin Sulfate	Teva	Lannett Holdings
6/10/2016	Paxil CR	Paroxetine Hydrochloride	Apotex	Kremers Urban Pharms
6/10/2016	Heparin Sodium	Heparin Sodium	Eurohealth Intl / Fresenius Kabi USA	Fresenius Kabi USA
6/13/2016	Minocycline Hydrochloride	Minocycline Hydrochloride	Sandoz	Aurobindo Pharma
6/13/2016	Ofirmev	Acetaminophen	Mallinckrodt	Paddock
6/14/2016	Precedex	Dexmedetomidine Hydrochloride	Hospira	Sandoz
6/14/2016	Avodart	Dutasteride	GlaxoSmithKline	Mylan
6/14/2016	Avapro	Irbesartan	Sanofi Aventis	Hisun Pharm Hangzhou
6/15/2016	Norco	Hydrocodone Bitartrate / Acetaminophen	Watson Labs / Actavis	Larken Labs
6/15/2016	Buphenyl	Sodium Phenylbutyrate	Horizon Pharma	Par
6/15/2016	Cubicin	Daptomycin	Cubist	Crane Pharms
6/16/2016	Fusilev	Levoleucovorin Calcium	Spectrum Pharms	Eurohlth Intl
6/17/2016	Lopid	Gemfibrozil	Pfizer Pharms	Cadila Pharms
6/17/2016	Abilify	Aripiprazole	Otsuka	Amneal
6/17/2016	Lamictal ODT	Lamotrigine	GlaxoSmithKline	Sciegen Pharms
6/20/2016	Robinul / Robinul Forte	Glycopyrrolate	Casper Pharma	Natco Pharma
6/20/2016	Activella	Amabelz	Amneal	Lupin
6/20/2016	Revatio	Sildenafil Citrate	Pfizer	Rubicon Res
6/21/2016	Advil Liqui-Gels / Advil Migraine Liqui- Gels (OTC)	Ibuprofen (OTC)	Pfizer	Puracap Pharm
6/23/2016	MS Contin	Morphine Sulfate	Purdue Pharma	Corepharma
6/23/2016	Aricept	Donepezil Hydrochloride	Eisai	Unichem Labs
6/23/2016	Fenoglide	Fenofibrate	Santarus	Mylan
6/23/2016	Primaquine	Primaquine Phosphate	Sanofi Aventis	Ingenius Pharms
6/23/2016	Nystatin / Triamcinolone Acetonide	Nystatin / Triamcinolone Acetonide	Taro	Glenmark Pharms
6/23/2016	Differin	Adapalene	Galderma Labs	Taro
6/24/2016	Mirapex ER	Pramipexole Dihydrochloride	Boehringer Ingelheim	Macleods Pharms
6/24/2016	Diazepam	Diazepam	Roxane	Lannett Holdings
6/27/2016	Vibramcycin	Doxycycline Hyclate	Pfizer	Amneal
6/29/2016	Naloxone Hydrochloride	Naloxone Hydrochloride	Hospira	Mylan

GENERICally Speaking Summer 2016

First Quarter

ANDA Litigation Settlements