ANDA Approvals

Spring 2016

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
1/4/2016	Diovan	Valsartan	Novartis	Ivax
1/5/2016	Gemzar	Gemcitabine Hydrochloride	Eli Lilly	Gland Pharma
1/6/2016	Naftin	Naftifine Hydrochloride	Merz Pharms	Taro
1/7/2016	Nystatin	Nystatin	Wockhardt	Pharm Assoc
1/7/2016	Dapsone	Dapsone	Jacobus	Fera Pharms
1/8/2016	Aygestin	Norethindrone Acetate	Duramed Res	Aurobindo
1/8/2016	Lodosyn	Carbidopa	Aton	Alvogen Malta
1/8/2016	Unasyn	Ampicillin / Sulbactam	Pfizer	Sagent Pharms
1/11/2016	Unasyn	Ampicillin / Sulbactam	Pfizer	Sagent Pharms
1/11/2016	Diovan	Valsartan	Novartis	Amneal
1/11/2016	Felbatol	Felbamate	Meda Pharms	Mylan
1/11/2016	Xyzal	Levocetirizine Dihydrochloride	UCB	MacLeods Pharms
1/12/2016	Singulair	Montelukast Sodium	Merck	Anbison Lab
1/13/2016	Prevacid 24 Hr (OTC)	Lansoprazole (OTC)	Novartis	Natco Pharma
1/13/2016	Zemplar	Paricalcitol	Abbvie	Amneal
1/13/2016	Pindolol	Pindolol	Mylan	Nostrum Labs
1/14/2016	Cyklokapron	Tranexamic Acid	Pharmacia and Upjohn	Aurobindo
1/14/2016	Avelox	Moxifloxacin Hydrochloride	Bayer	Crossmedika
1/14/2016	Zemplar	Paricalcitol	Abbvie	Aurobindo
1/15/2016	Avalide	Irbesartan / Hydrochlorothiazide	Sanofi Aventis	Int'l Specialty Chemicals
1/19/2016	Potassium Chloride	Potassium Chloride	Actavis	Glenmark
1/19/2016	Rifadin	Rifampin	Sanofi Aventis	Watson
1/20/2016	Silenor	Doxepin Hydrochloride	Pernix Theraps	Mylan
1/21/2016	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Gland Pharma
1/21/2016	Klor-Con M20	Potassium Chloride	Upsher Smith	Novel Labs
1/22/2016	Vfend	Voriconazole	PF Prism	Aurobindo
1/26/2016	Exjade	Deferasirox	Novartis	Actavis
1/26/2016	Protonix	Pantoprazole Sodium	Wyeth	Amneal
1/27/2016	Lescol XL	Fluvastatin Sodium	Novartis	Teva
1/27/2016	Ortho Cyclen-28	Norgestimate / Ethinyl Estradiol	Janssen	Jai Pharma
1/27/2016	Zyprexa	Olanzapine	Eli Lilly	Qilu Pharm
1/27/2016	Dexedrine	Dextroamphetamine Sulfate	Amedra Pharms	Mylan
1/28/2016	Uroxatral	Alfuzosin Hydrochloride	Concordia Pharms	Unichem Labs
1/29/2016	Minocycline Hydrochloride	Minocycline Hydrochloride	Par	Sun Pharm
1/29/2016	Buprenorphine Hydrochloride	Burprenorphine Hydrocloride	Roxane	Sun Pharm
1/29/2016	Peridex	Periogard	3M	Colgate-Palmolive
2/1/2016	Maxipime	Cefepime Hydrochloride	Hospira	Qilu Pharm
2/1/2016	Keppra	Levetiracetam	UCB	Aurobindo
2/1/2016	Lidocaine	Lidocaine	Fougera	Teligent Pharma
2/1/2016	Celebrex	Celecoxib	GD Searle	Aurobindo
2/2/2016	Isosulfan Blue	Isosulfan Blue	Mylan	Aurobindo
2/3/2016	Xenazine	Tetrabenazine	Valeant	Hetero Labs
2/3/2016	Ammonia N 13	Ammonia N 13	Feinstein	MA General Hosp
2/4/2016	Neurontin	Gabapentin	Pfizer	Sciegen Pharms
2/5/2016	Zyvox	Linezolid	Pharmacia and Upjohn	Gate Pharms
2/5/2016	Boniva	Ibandronate Sodium	Roche	Accord Healthcare
2/5/2016	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Barr	Actavis
2/8/2016	Diovan HCT	Valsartan / Hydrochlorothiazide	Novartis	Prinston
2/9/2016	Precedex	Dexmedetomidine Hydrochloride	Hospira	Accord Healthcare
2/9/2016	Zovia 1/50E-28	Ethynodiol Diacetate / Ethinyl Estradiol	Watson Labs	Jai Pharma
2/9/2016	Wellbutrin SR	Bupropion Hydrochloride	GlaxoSmithKline	Invagen Pharms
2/10/2016	Temodar	Temozolomide	Merck Sharp Dohme	Kremers Urban
2/10/2016	Levaquin in Dextrose 5% in Plastic Container	Levofloxacin in Dextrose 5% in Plastic Container	Janssen	Aurobindo
2/16/2016	Adderall XR 30	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Shire	Impax Labs
2/16/2016	Macrodantin	Nitrofurantoin	Alvogen Malta	Sun Pharm
2/16/2016	Solu-Medrol	Methylprednisolone Sodium Succinate	Pharmacia and Upjohn	Hikma Farmaceutica
2/16/2016	Pristiq	Desvenlafaxine Succinate	Wyeth	Roxane
2/17/2016	Sustiva	Efavirenz	Bristol Myers Squibb	Mylan
2/17/2016	Flouorouracil	Flouorouracil	Accord Healthcare / Fresenius Kabi USA/Teva	Sagent Pharms
2/17/2016	Lodosyn	Carbidopa	Aton	Edenbridge Pharms
2/18/2016	Maxalt	Rizatriptan Benzoate	Merck	Alkem Labs
2/18/2016	Neurontin	Gabapentin	Pfizer	Sciegen Pharms
2/18/2016	Monodox	Doxycycline	Aqua Pharms	Zydus
2/18/2016	Dantrium	Dantrolene Sodium	Par Sterile Products	Mylan
2/19/2016	Claforan	Cefotaxime Sodium	Sanofi Aventis / US Pharm Holdings	Hospira
2/19/2016	Aricept	Donepezil Hydrochloride	Eisai	Dexcel Pharma
2/19/2016	Imitrex	Sumatriptan	GlaxoSmithKline	Lannett
2/23/2016	Ortho Tri-Cyclen Lo	Norgestimate / Ethinyl Estradiol	Janssen	Glenmark
2/23/2016	Keppra XR	Levetiracetam	UCB	Intellipharmaceutics
2/23/2016	Zipsor	Diclofenac Potassium	Depomed	Bionpharma
2/24/2016	Zemplar	Paricalcitol	Abbvie	Lotus Pharm
2/24/2016	Ammonul	Sodium Phenylacetate / Sodium Benzoate	Medicis	Ailex Pharms
2/25/2016	Amidate	Etomidate	Hospira	Hikma Farmaceutica
2/25/2016	Cyklokapron	Tranexamic Acid	Pharmacia and Upjohn	North Creek Pharms
2/25/2016	Topicort	Desoximetasone	Taro	Teligent Pharma
2/26/2016	Nicorette (OTC)	Nicotine Polacrilex (OTC)	GlaxoSmithKline	Actavis
2/29/2016	Clarithromycin	Clarithromycin	Teva	Allied Pharma
2/29/2016	Metadate ER	Methylphenidate Hydrochloride	UCB	Tedor Pharma
2/29/2016	Acyclovir Sodium	Acyclovir Sodium	Fresenius Kabi USA	Hikma Pharms
2/29/2016	Glucovance	Glyburide / Metformin Hydrochloride	Bristol Myers Squibb	Zydus
2/29/2016	Ditropan XL	Oxybutynin Chloride	Janssen	Accord Healthcare
2/29/2016	Acetadote	Acetylcysteine	Cumberland Pharms	Aurobindo
2/29/2016	Flonase Allergy Relief (OTC)	Fluticasone Propionate (OTC)	GlaxoSmithKline	Apotex
3/1/2016	Wellbutrin SR	Bupropion Hydrochloride	GlaxoSmithKline	Sciegen Pharms
3/2/2016	Magnesium Sulfate in Dextrose 5% in Plastic Container	Magnesium Sulfate in Dextrose 5% in Plastic Containers	Hospira	HQ Specialty Pharma
3/3/2016	Rifadin	Rifampin	Sanofi Aventis	Hikma Pharms
3/3/2016	Axert	Almotriptan Malate	Janssen	Ajanta Pharma
3/4/2016	Potassium Chloride	Potassium Chloride	Actavis	Tris Pharma
3/4/2016	Epivir	Lamivudine	VIIV Healthcare	Mylan
3/7/2016	Oxistat	Oxiconazole Nitrate	Fougera Pharms	Taro
3/7/2016	Magnesium Sulfate in Dextrose 5% in Plastic Container	Magnesium Sulfate in Dextrose 5% in Plastic Container	Hospira	Fresenius Kabi USA
3/8/2016	Seroquel	Quetiapine Fumarate	AstraZeneca	Unichem Labs
3/8/2016	Pulmicort Respules	Budesonide	AstraZeneca	Teva
3/8/2016	Aggrenox	Aspirin / Dipyridamole	Boehringer Ingelheim	Amneal
3/8/2016	Children's Cetirizine Hydrochloride Allergy	Children's Cetirizine Hydrochloride Allergy	Sandoz	Novel Labs
3/8/2016	Zofran Preservative Free	Ondansetron Hydrochloride Preservative Free	Novartis	Accord Healthcare
3/11/2016	Boniva	Ibandronate Sodium	Hoffmann LA Roche	Aurobindo
3/11/2016	Frova	Frovatriptan Succinate	Endo	Glenmark
3/11/2016	Plan B One-Step	Levonorgestrel	Teva Branded	Novast Labs
3/14/2016	Neurontin	Gabapentin	Parke Davis	Tris Pharma
3/15/2016	Azilect	Rasagiline Mesylate	Teva Branded	Orchid Healthcare
3/15/2016	Zyprexa	Olanzapine	Eli Lilly	Invagen
3/15/2016	Zyvox	Linezolid	Pharmacia and Upjohn	Fresenius Kabi USA
3/15/2016	Magnesium Sulfate in Plastic Container	Magnesium Sulfate in Plastic Container	Hospira	Fresenius Kabi USA
3/16/2016	Zyprexa Zydis	Olanzapine	Eli Lilly	Invagen
3/16/2016	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Barr	Novel Labs
3/16/2016	Celebrex	Celecoxib	GD Searle	MacLeods
3/17/2016	Precedex	Dexmedetomidine Hydrochloride	Hospira	Aurobindo
3/17/2016	Avodart	Dutasteride	GlaxoSmithKline	Intergel Pharms
3/17/2016	Norpramin	Desipramine Hydrochloride	US Pharm Holdings	Amneal
3/18/2016	Valcyte	Valganciclovir Hydrochloride	Hoffmann LA Roche	Hetero Labs
3/18/2016	Aleve (OTC)	Naproxen Sodium (OTC)	Bayer	Aurobindo
3/18/2016	Voltaren	Diclofenac Sodium	GlaxoSmithKline	Amneal
3/22/2016	Nasonex	Mometasone Furoate	Merck Sharp Dohme	Apotex
3/22/2016	Xopenex	Levalbuterol Hydrochloride	Oak Pharms	Ritedose
3/22/2016	Ofirmev	Acetaminophen	Mallinckrodt	Sandoz
3/22/2016	Evista	Raloxifene Hydrochloride	Eli Lilly	Novel Labs
3/23/2016	Femcon Fe	Norethindrone / Ethinyl Estradiol / Ferrous Fumarate	Allergan	Lupin
3/23/2016	Temodar	Temozolomide	Merck Sharp Dohme	Lannett
3/23/2016	Vfend	Voriconazole	PF Prism CV	Alvogen
3/24/2016	Temodar	Temozolomide	Merck Sharp Dohme	Roxane
3/24/2016	Treanda	Bendamustine Hydrochloride	Cephalon	Glenmark
3/24/2016	Treanda	Bendamustine Hydrochloride	Cephalon	Innopharma
3/24/2016	Thyroshield (OTC)	Potassium Iodide (OTC)	Arco Pharms	Mission Pharmacal
3/25/2016	Cubicin	Daptomycin	Cubist	Teva
3/25/2016	Zovirax	Acyclovir	Delcor Asset	Zydus
3/25/2016	Exelon	Rivastigmine Tartrate	Novartis	Aurobindo
3/25/2016	Yasmin	Drospirenone / Ethinyl Estradiol	Bayer	Glenmark
3/25/2016	Plan B One-Step	Levonorgestrel	Teva Branded	Glenmark
3/28/2016	Potassium Chloride	Potassium Chloride	Actavis	Kremers Urban
3/28/2016	Carboplatin	Carboplatin	Pharmachemie / Teva	Sanja Pharms
3/28/2016	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Aurobindo
3/28/2016	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Barr	Nesher Pharms
3/29/2016	Diamox	Acetazolamide	Teva Branded	Nostrum Labs
3/30/2016	Neoprofen	Ibuprofen Lysine	Recordati Rare	Exela Pharma Science
3/30/2016	Rilutek	Riluzole	Covis Pharma	Alkem Labs
3/30/2016	Protonix IV	Pantoprazole Sodium	Wyeth Pharms Inc	Aurobindo
3/31/2016	Lexapro	Escitalopram Oxalate	Forest Labs	MacLeods Pharms
3/31/2016	Valcyte	Valganciclovir Hydrochloride	Hoffmann LA Roche	Aurobindo
3/31/2016	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lehigh Valley	Ani Pharms
3/31/2016	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA/Hospira	Aurobindo

GENERICally Speaking Spring 2016

First Quarter

ANDA Litigation Settlements