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ANDA Approvals
Spring 2017
| 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 |
GENERICally Speaking Spring 2017
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