ANDA Approvals

Spring 2017

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/3/2017 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Actavis
1/3/2017 Robinul / Robinul Forte Glycopyrrolate Casper Pharma Appco Pharma
1/4/2017 Maxipime Cefepime Hydrochloride Hospira Sagent Pharms
1/4/2017 Levetiracetam in Sodium Chloride Levetiracetam in Sodium Chloride HQ Speciality Pharma Aurobindo Pharma
1/5/2017 Proscar Finasteride Merck Alkem Labs
1/6/2017 Propecia Finasteride Merck Alkem Labs
1/6/2017 Cymbalta Duloxetine Hydrochloride Eli Lilly Ajanta Pharma
1/9/2017 Abilify Aripiprazole Otsuka Stason Pharms
1/9/2017 Lipitor Atorvastatin Calcium Pfizer Invagen Pharms
1/10/2017 Patanol Olopatadine Hydrochloride Novartis Akorn
1/10/2017 Choline C-11 Choline C-11 MCPRF WA Univ Sch Med
1/11/2017 Maxalt-MLT Rizatriptan Benzoate Merck Panacea Biotec
1/13/2017 Methotrexate Sodium Methotrexate Sodium Dava Pharms Zydus Pharms USA
1/13/2017 Zosyn Piperacillin / Tazobactam Wyeth Apollo Pharms
1/13/2017 Zosyn Piperacillin / Tazobactam Wyeth Apollo Pharms
1/17/2017 Xyrem Sodium Oxybate Jazz Pharms West-Ward Pharms
1/18/2017 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Sandoz
1/18/2017 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Impax Labs
1/18/2017 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Par Pharm
1/19/2017 Robaxin Methocarbamol West-Ward Pharms Renaissance Pharma
1/20/2017 Paxil CR Paroxetine Hydrochloride Apotex Lupin
1/20/2017 Flomax Tamsulosin Hydrochloride Boehringer Ingelheim Macleods Pharms
1/20/2017 Taxotere Docetaxel Sanofi Aventis / Accord Healthcare DFB Oncology
1/20/2017 Topicort Desoximetasone Taro Perrigo
1/23/2017 Aleve ( OTC) Naproxen Sodium (OTC) Bayer LNK Intl
1/23/2017 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim MacLeods Pharms
1/23/2017 Ampyra Dalfampridine Acorda Aurobindo Pharma
1/23/2017 Ampyra Dalfampridine Acorda Actavis
1/24/2017 Ambien CR Zolpidem Tartrate Sanofi Aventis    Sun Pharma Global
1/24/2017 Dibenzyline Phenoxybenzamine Hydrochloride Concordia Pharms  Par Pharm
1/26/2017 Zithromax Azithromycin Pfizer Mylan Labs
1/26/2017 Zanaflex Tizanidine Hydrochloride Acorda Par Pharm
1/27/2017 Nimbex Preservative Free / Nimbex Cisatracurium Besylate Preservative Free Abbvie Jiangsu Hengrui Med
1/27/2017 Namzaric Memantine Hydrochloride / Donepezil Hydrochloride Forest Labs Amneal Pharms
1/31/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Fresnius Kabi USA
1/31/2017 Patanase Olopatadine Hydrochloride Novartis Perrigo
1/31/2017 Xopenex Levalbuterol Hydrochloride Oak Pharms Aurobindo Pharma
1/31/2017 Xenazine Tetrabenazine Valeant Pharms Apicore US
2/1/2017 Triamicnolone Acetonide Triamcinolone Acetonide Mylan Lupin
2/2/2017 Pravachol Pravastatin Sodium Bristol Myers Squibb Aurobindo Pharma
2/2/2017 Inspra Eplerenone GD Searle Mylan
2/2/2017 Plavix Clopidogrel Bisulfate Sanofi Aventis CSPC OUYI Pharm
2/2/2017 Femcon FE Nexesta Fe  Apil Aurobindo Pharma
2/3/2017 Livalo Pitavastatin Calcium Kowa Orient Pharma
2/3/2017 Livalo Pitavastatin Calcium Kowa Sawai USA
2/6/2017 Heparin Sodium Heparin Sodium Fresenius Kabi USA / West-Ward Pharms Gland Pharma
2/6/2017 Suprax Cefixime Lupin Ltd Belcher Pharms
2/7/2017 Amidate Etomidate Hospira Mylan
2/8/2017 Robaxin / Robaxin-750 Methocarbamol Auxilium Pharms Atlas  Pharms
2/10/2017 Activella Estradiol / Norethindrone Acetate Amneal Pharms Mylan
2/10/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Gland Pharma
2/10/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Cipla
2/13/2017 Exelon Rivastigmine Tartrate Novartis Cadila Pharms
2/13/2017 Fusilev Levoleucovorin Calcium Spectrum Pharms Actavis
2/13/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Gland Pharma
2/13/2017 Avelox Moxifloxacin Hydrochloride Bayer Healthcare Novel Labs
2/13/2017 Fusilev Levoleucovorin Calcium Spectrum Pharms Amneal Pharms
2/13/2017 Ella Logilia Lab HRA Pharma Teva
2/14/2017 Reclast Zoledronic Acid Novartis Mylan
2/16/2107 Clobex Clobetasol Propionate Galderma Labs Zydus Pharms USA
2/16/2017 Diflucan Fluconazole Pfizer Zydus Pharms USA
2/17/2017 Geodon Ziprasidone Hydrochloride Pfizer MacLeods Pharms
2/17/2017 Toviaz Fesoterodine Fumarate Pfizer Aurobindo Pharma
2/17/2017 Aciphex Rabeprazole Sodium Eisai Aurobindo Pharma
2/17/2017 Bentyl / Bentyl Preservative Free Dicyclomine Hydrochloride Forest Labs Luitpold Pharms
2/22/2017 Zyvox Linezolid Pharmacia and Upjohn Zydus Pharms USA
2/23/2017 Glucophage XR Metformin Hydrochloride Bristol Myers Squibb Intellipharmaceutics
2/23/2017 Suprep Bowel Prep Kit Sodium Sulfate / Potassium Sulfate / Magnesium Sulfate Braintree Labs Novel Labs
2/23/2017 Sporanox Itraconazole Janssen Jubilant Generics
2/23/2017 Edecrin Ethacrynic Acid Aton West-Ward Pharms
2/24/2017 Amidate Etomidate Hospira Aurobindo Pharma
2/24/2017 Tamiflu Oseltamivir Phosphate Roche Nesher Pharms
2/27/2017 Temodar Temozolomide Merck Sharp Dohme Accord Healthcare
2/27/2017 Dacogen Decitabine Otsuka Pharm Accord Healthcare
2/27/2017 Zomig Zolmitriptan IPR PLD Acquisitions
2/28/2017 Alkeran Melphalan Hydrochloride Apotex Sagent Pharms
2/28/2017 Fludarabine Phosphate Fludarabine Phosphate Sandoz Actavis
2/28/2017 Requip Ropinirole Hydrochloride GlaxoSmithKline Accord Healthcare
2/28/2017 Cellcept Mycophenolate Mofetil Hydrochloride Roche Palo Akorn
2/28/2017 Axiron Testosterone Eli Lilly Perrigo
2/28/2017 Xeloda Capecitabine Hoffmann LA Roche Amneal Pharms
2/28/2017 Viramune XR Nevirapine Boehringer Ingelheim Aurobindo Pharma
2/28/2017 Prometrium Progesterone Virtus Pharms Dr Reddys Labs
2/28/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Amneal Pharms
3/2/2017 Zyvox Linezolid Pharmacia and Upjohn Sagent Pharms
3/3/2017 Epivir Lamivudine VIIV Healthcare Cipla
3/3/2017 Ritalin Methylphenidate Hydrochloride Novartis Nostrum Labs
3/3/2017 Zanaflex Tizanidine Hydrochloride Acorda Zydus Pharms USA
3/6/2017 Nexium IV Esomeprazole Sodium Astrazeneca Deva Holding
3/7/2017 Maxalt-MLT Rizatriptan Benzoate Merck Unichem Labs
3/7/2017 Maxalt Rizatriptan Benzoate Merck Unichem Labs
3/8/2017 Nulytely / Nulytely-Flavored Peg-3350 / Potassium Chloride / Sodium Bicarbonate / Sodium Chloride Braintree Breckenridge Pharms
3/9/2017 Zemplar Paricalcitol Abbvie Amneal Pharms
3/10/2017 Aromasin Exemestane Pharmacia and Upjohn Mylan
3/10/2017 Neurontin Gabapentin Pfizer Teva
3/14/2017 Metrogel Metronidazole Galderma Labs Taro Pharm
3/14/2017 Zanaflex Tizanidine Hydrochloride Acorda Par Pharm
3/17/2017 Astelin Azelastine Hydrochloride Meda Pharms Upsher-Smith Labs
3/17/2017 Zyflo CR Zileuton Chiesi USA Pack Pharms
3/17/2017 Mucinex DM (OTC) Guaifenesin / Dextromethorphan Hydrobromide (OTC) Reckitt Benckiser Aurobindo Pharma
3/17/2017 Zosyn Piperacillin / Tazobactam Wyeth Wockhardt Bio 
3/21/2017 Crestor Rosuvastatin Calcium IPR Alkem Labs
3/21/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Accord Healthcare
3/22/2017 Zosyn Piperacillin / Tazobactam Wyeth Wockhardt Bio
3/22/2017 Ultracet Tramadol Hydrochloride / Acetaminophen Janssen Aurobindo Pharma
3/22/2017 Alkeran Melphalan Apotex Alvogen Malta
3/22/2017 TOBI Tobramycin Novartis Lupin
3/23/2017 Cymbalta Duloxetine Hydrochloride Eli Lilly MacLeods Pharms
3/24/2017 Aricept Donepezil Hydrochloride Eisai Zhejiang Hisun Pharm
3/24/2017 Venlafaxine Hydrochloride Venlafaxine Hydrochloride Osmotica Pharm Nostrum Labs
3/24/2017 Busulflex Busulfan Otsuka Pharm Pharmascience
3/24/2017 Neurontin  Gabapentin Pfizer Epic Pharma
3/27/2017 Lipitor Atorvastatin Calcium Pfizer Teva
3/27/2017 Merrem Meropenem Astrazeneca Aurobindo Pharma
3/27/2017 Desonide Desonide Perrigo Hi-Tech Pharmacal
3/28/2017 Epzicom Abacavir Sulfate / Lamivudine ViiV Healthcare Cipla
3/28/2017 Epzicom Abacavir Sulfate / Lamivudine ViiV Healthcare Lupin
3/29/2017 Femcon FE Noretindrone / Ethinyl Estradiol / Ferrous Fumarate Apil  Accord Healthcare
3/31/2017 Rapaflo Silodosin Allergan Sandoz
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