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ANDA Approvals
Summer 2017
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 4/3/2017 | Nasonex | Mometasone Furoate | Merck Sharp Dohme | Amneal |
| 4/3/2017 | Tazorac / Avage | Tazarotene | Allergan | Taro |
| 4/4/2017 | Ativan | Lorazepam | West-Ward Pharms | Sagent Agila |
| 4/4/2017 | Celebrex | Celecoxib | GD Searle | Jubilant Generics |
| 4/6/2017 | Wellbutrin XL | Bupropion Hydrochloride | Valeant | Lupin |
| 4/7/2017 | Avodart | Dutasteride | GlaxoSmithKline | Marksans Pharma |
| 4/7/2017 | Seasonique | Simpesse | Teva | Aurobindo |
| 4/7/2017 | Entocort EC | Budesonide | Perrigo | Appco Pharma |
| 4/10/2017 | Naftin | Naftifine Hydrochloride | Sebela Ireland | Tolmar |
| 4/12/2017 | Wellbutrin XL | Bupropion Hydrochloride | Valeant | Sciegen Pharms |
| 4/14/2017 | Perphenazine | Perphenazine | Sandoz | Mylan |
| 4/18/2017 | Temodar | Temozolomide | Merck Sharp Dohme | Watson / Teva |
| 4/18/2017 | Integrilin | Eptifibatide | Schering | Akorn |
| 4/18/2017 | Singulair | Montelukast Sodium | Merck | CSPC Ouyi Pharm |
| 4/18/2017 | Amidate | Etomidate | Hospira | Gland Pharma |
| 4/19/2017 | Dexilant | Dexlansoprazole | Takeda | Par |
| 4/20/2017 | Felbatol | Felbamate | Mylan | Taro |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Teva |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Torrent |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Alembic |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Aurobindo |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | MacLeods |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Zydus |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Jubilant Generics |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Alkem Labs |
| 4/24/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Accord Healthcare |
| 4/24/2017 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Teva |
| 4/24/2017 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Alembic |
| 4/24/2017 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Aurobindo |
| 4/24/2017 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Prinston |
| 4/24/2017 | Singulair | Montelukast Sodium | Merck | CSPC Ouyi Pharm |
| 4/25/2017 | Rayos | Prednisone | Horizon Pharma | Actavis Labs |
| 4/26/2017 | Vytorin | Ezetimibe / Simvastatin | Merck Sharp & Dohme | Dr. Reddys |
| 4/26/2017 | Vytorin | Ezetimibe / Simvastatin | Merck Sharp & Dohme | Impax |
| 4/26/2017 | Vytorin | Ezetimibe / Simvastatin | Merck Sharp & Dohme | Watson |
| 4/26/2017 | Precedex | Dexmedetomidine Hydrochloride | Hospira | West-Ward Pharms |
| 4/26/2017 | Singulair | Montelukast Sodium | Merck | Perrigo |
| 4/26/2017 | Temodar | Temozolomide | Merck Sharp Dohme | Deva Holding |
| 4/26/2017 | Bloxiverz | Neostigmine Methylsulfate | Eclat Pharms | Par Sterile Products |
| 4/27/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Lupin |
| 4/27/2017 | Cortef | Hydrocortisone | Pharmacia and Upjohn | PII |
| 4/27/2017 | Sabril | Vigabatrin | Lundbeck Pharms | Par Pharm |
| 4/28/2017 | Ativan | Lorazepam | West-Ward Pharms | Sagent Agila |
| 4/28/2017 | Ortho-Novum 1/35-28 | Norethindrone / Ethinyl Estradiol | Janssen | Accord Healthcare |
| 4/28/2017 | Clobex | Clobetasol Propionate | Galderma Labs | Akorn |
| 4/28/2017 | Dymista | Azelastine Hydrochloride / Fluticasone Propionate | Mylan | Apotex |
| 4/28/2017 | Mepron | Atovaquone | GlaxoSmithKline | Paddock |
| 5/2/2017 | Ultracet | Tramadol Hydrochloride / Acetaminophen | Janssen | MacLeods |
| 5/3/2017 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Torrent |
| 5/3/2017 | Micardis | Telmisartan | Boehringer Ingelheim | Prinston |
| 5/4/2017 | Entocort EC | Budesonide | Perrigo | Zydus |
| 5/4/2017 | Daypro | Oxaprozin | GD Searle | Amneal |
| 5/5/2017 | Combivir | Lamivudine / Zidovudine | ViiV Healthcare | Aurobindo Pharma |
| 5/5/2017 | Elestat | Epinastine Hydrohcloride | Allergan | Akorn |
| 5/5/2017 | Avelox in Sodium Chloride 0.8% in Plastic Container | Moxifloxacin Hydrochloride in Sodium Chloride 0.8% in Plastic Container | Bayer Healthcare | Mylan |
| 5/5/2017 | Calan SR | Verapamil Hydrochloride | Pfizer | Cadila Pharms |
| 5/5/2017 | Motrin IB (OTC) | Ibuprofen (OTC) | Johnson and Johnson | Aiping Pharm |
| 5/8/2017 | Ammonul | Sodium Phenylacetate / Sodium Benzoate | Medicis | Maia Pharms |
| 5/9/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Par |
| 5/9/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Accord Healthcare |
| 5/9/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Intellipharmaceutics |
| 5/9/2017 | Clolar | Clofarabine | Genzyme | Abon Pharms |
| 5/9/2017 | Metronidazole in Plastic Container / Metro I.V. in Plastic Container / Flagyl I.V. RTU in Plastic Container | Metronidazole in Plastic Container | Hospira / B Braun / Baxter Healthcare | Mylan |
| 5/9/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Pharmadax |
| 5/11/2017 | Baraclude | Entecavir | Bristol Myers Squibb | Sandoz |
| 5/11/2017 | Ritalin | Methylpenidate Hydrochloride | Novartis | Abhai |
| 5/11/2017 | Soma | Carisoprodol | Mylan | Nostrum Labs |
| 5/12/2017 | Precedex | Dexmedetomidine Hydrochloride | Hospira | Luitpold Pharms |
| 5/12/2017 | Oxaliplatin / Eloxatin | Oxaliplatin | Teva / Sanofi Aventis | Luitpold Pharms |
| 5/12/2017 | Haldol | Haloperidol Decanoate | Janssen | Gland Pharma |
| 5/12/2017 | Glucotrol XL | Glipizide | Pfizer | Aurobindo |
| 5/12/2017 | Trilipix | Fenofibric Acid | AbbVie | Alembic |
| 5/15/2017 | Azilect | Rasagiline Mesylate | Teva | Mylan |
| 5/15/2017 | Zutripro | Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride | Cypress Pharm | Bio-Pharm |
| 5/15/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Aurobindo |
| 5/15/2017 | Pennsaid | Diclofenac Sodium | Horizon Pharma | Actavis |
| 5/15/2017 | Macrobid | Nitrofurantoin (Monohydrate/ Macrocrystals) | Alvogen Malta | Amneal |
| 5/15/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Jubilant Generics |
| 5/15/2017 | Doxil (Liposomal) | Doxorubicin Hydrochloride (Liposomal) | Janssen | Dr. Reddys |
| 5/17/2017 | Nexium IV | Esomeprazole Sodium | AstraZeneca | Mylan Labs |
| 5/17/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Lupin |
| 5/17/2017 | Lexapro | Escitalopram Oxalate | Forest Labs | Amneal |
| 5/17/2017 | Tamiflu | Oseltamivir Phosphate | Roche | Amneal |
| 5/18/2017 | Cymbalta | Duloxetine Hydrochloride | Lilly | Prinston |
| 5/22/2017 | Argatroban in Sodium Chloride | Argatroban in Sodium Chloride | Sandoz | Gland Pharma |
| 5/23/2017 | Namenda | Memantine Hydrochloride | Forest Labs | Strides Pharma |
| 5/23/2017 | Abilify | Aripiprazole | Otsuka | Orchid Healthcare |
| 5/23/2017 | Zestoretic | Lisinopril / Hydroclorothiazide | Alvogen Malta | Invagen Pharms |
| 5/23/2017 | Gemcitabine Hydrochloride | Gemcitabine Hydrochloride | Hospira | Apotex |
| 5/24/2017 | Luxiq | Betamethasone Valerate | Mylan | RiconPharma |
| 5/24/2017 | Luxiq | Betamethasone Valerate | Mylan | Taro Pharm |
| 5/24/2017 | Hectorol | Doxercalciferol | Genzyme | Amneal |
| 5/24/2017 | Hectorol | Doxercalciferol | Genzyme | Amneal |
| 5/25/2017 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Glenmark |
| 5/25/2017 | Sodium Chloride 0.9% in Plastic Container | Sodium Chloride 0.9% in Plastic Container | B Braun / Baxter Healthcare / Hospira / ICU Medical Inc | Laboratorios Grifols |
| 5/26/2017 | Angiomax | Bivalirudin | The Medicines Co | Dr Reddys |
| 5/26/2017 | Camptosar | Irinotecan Hydrochloride | Pfizer | Ingenus Pharms |
| 5/26/2017 | DDAVP | Desmopressin Acetate | Ferring | Heritage Pharma |
| 5/30/2017 | Strattera | Atomoxetine Hydrochloride | Eli Lilly | Apotex |
| 5/30/2017 | Strattera | Atoxoxetine Hydrochloride | Eli Lilly | Aurobindo Pharma |
| 5/30/2017 | Strattera | Atomoxetine Hydrochloride | Eli Lilly | Glenmark |
| 5/30/2017 | Strattera | Atoxoxetine Hydrochloride | Eli Lilly | Teva |
| 5/30/2017 | Zyprexa Zydis | Olanzapine | Eli Lilly | Ajanta Pharma |
| 5/30/2017 | Motrin IB (OTC) | Ibuprofen (OTC) | Johnson and Johnson | Strides Pharma |
| 5/30/2017 | Felbatol | Felbamate | Mylan | Zydus |
| 5/31/2017 | Dacogen | Decitabine | Otsuka Pharm | Pharmascience |
| 6/1/2017 | Remeron Soltab | Mirtazapine | Organon USA | Zydus |
| 6/1/2017 | Levaquin | Levofloxacin | Janssen | Zydus |
| 6/2/20017 | Corgard | Nadolol | US Worldmeds | Amneal |
| 6/5/2017 | Lialda | Mesalamine | Shire | Zydus |
| 6/5/2017 | Comtan | Entacapone | Orion Pharma | MacLeods |
| 6/8/2017 | Avalide | Irbesartan / Hydrochlorothiazide | Sanofi Aventis | West-Ward Pharms |
| 6/8/2017 | Cardizem CD | Diltiazem Hydrochloride | Valeant | Sun Pharm |
| 6/9/2017 | Vituz | Hydrocodone Bitartrate / Chlorpheniramine Maleate | Cypress Pharm | Acella Pharms |
| 6/12/2017 | Roxicodone | Oxycodone Hydrochloride | Mallinckrodt | Novel Labs |
| 6/12/2017 | Zetia | Ezetimibe | Merck Sharp & Dohme | Zydus |
| 6/12/2017 | Zetia | Ezetimibe | Merck Sharp & Dohme | OHM Labs |
| 6/12/2017 | Zetia | Ezetimibe | Merck Sharp & Dohme | Apotex |
| 6/12/2017 | Zetia | Ezetimibe | Merck Sharp & Dohme | Amneal |
| 6/12/2017 | Sporanox | Itraconazole | Janssen | Alkem Labs |
| 6/13/2017 | Renvela | Sevelamer Carbonate | Genzyme | Aurobindo |
| 6/13/2017 | Rocaltrol | Calcitriol | Validus Pharms | Amneal |
| 6/14/2017 | Acticlate | Doxycycline Hyclate | Aqua Pharms | Mayne Pharma |
| 6/15/2017 | Skelaxin | Metaxalone | King Pharms | Actavis Labs |
| 6/15/2017 | Loestrin 24 FE | Aurovela 24 FE | Apil | Aurobindo |
| 6/15/2017 | Loestrin FE 1.5/30 | Aurovela FE 1.5/30 | Apil | Aurobindo |
| 6/16/2017 | Niaspan | Niacin | AbbVie | Lannett |
| 6/16/2017 | Zyprexa | Olanzapine | Lilly | Hikma |
| 6/16/2017 | Nimbex | Cisatracurium Besylate Preservative Free | AbbVie | Accord Healthcare |
| 6/16/2017 | Felbatol | Felbamate | Mylan | Taro Pharm |
| 6/16/2017 | Relpax | Eletriptan Hydrobromide | Pfizer | Zydus |
| 6/19/2017 | Dantrium | Dantrolene Sodium | Par | Hikma |
| 6/20/2017 | Feldene | Piroxicam | Pfizer | PII |
| 6/20/2017 | Brisdelle | Paroxetine Mesylate | Sebela Ireland | Actavis Labs |
| 6/20/2017 | Flagyl | Metronidazole | GD Searle | Orit Labs |
| 6/20/2017 | Atacand | Candesartan Cilexetil | AstraZeneca | Alembic Pharms |
| 6/21/2017 | Gleevec | Imatinib Mesylate | Novartis | Mylan |
| 6/22/2017 | Morphine Sulfate | Morphine Sulfate | West-Ward Pharms | Rhodes Pharms |
| 6/22/2017 | Robaxin | Methocarbamol | West-Ward Pharms | Luitpold Pharms |
| 6/23/2017 | Baraclude | Entecavir | Bristol Myers Squibb | Zydus |
| 6/23/2017 | Vidaza | Azacitidine | Celgene | Natco Pharma |
| 6/26/2017 | Ditropan XL | Oxybutynin Chloride | Janssen | Zydus |
| 6/27/2017 | Benzaclin | Clindamycin Phosphate / Benzoyl Peroxide | Valeant | Tolmar |
| 6/27/2017 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Micro Labs |
| 6/27/2017 | Dexedrine | Dextroamphetamine Sulfate | Amedra Pharms | Nesher Pharms |
| 6/27/2017 | Children's Motrin (OTC) | Ibuprofen (OTC) | Johnson and Johnson | Taro |
| 6/28/2017 | Tobrex | Tobramycin | Novartis | Somerset Theraps |
| 6/28/2017 | Cleocin | Clindamycin Phosphate in 5% Dextrose in Plastic Container | Pharmacia and Upjohn | Celerity Pharms |
| 6/30/2017 | Zomig | Zolmitriptan | IPR | Appco Pharma |
| 6/30/2017 | Wellbutrin XL | Bupropion Hydrochloride | Valeant | Anbison Lab |
| 6/30/2017 | Wellbutrin XL | Bupropion Hydrochloride | Valeant | Jubilant Generics |
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