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 |