| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 7/7/2015 | Axert | Almotriptan Malate | Janssen Pharms | Teva Pharms USA |
| 7/7/2015 | Zyvox | Linezolid | Pharmacia and Upjohn | Hospira |
| 7/8/2015 | Soma | Carisoprodol | Meda Pharms | Indicus Pharma |
| 7/8/2015 | Pennsaid | Diclofenac Sodium | Nuvo Research | IGI Labs |
| 7/8/2015 | Flecainide Acetate | Flecainide Acetate | Roxane | Aurobindo Pharma |
| 7/9/2015 | Phoslo Gelcaps | Calcium Acetate | Fresenius Medical | Lupin |
| 7/9/2015 | Macrobid | Nitrofurantoin (Monohydrate/ Macrocrystals) | Alvogen | Watson Labs |
| 7/10/2015 | Klor-Con | Pottasium Chloride | Actavis | Upsher Smith |
| 7/10/2015 | Viramune XR | Nevirapine | Boehringer Ingelheim | Alvogen Pine Brook |
| 7/10/2015 | Travatan Z | Travoprost | Alcon Pharms | Apotex |
| 7/13/2015 | Pataday | Olopatadine Hydrochloride | Alcon Pharms | Barr Labs |
| 7/13/2015 | Zofran | Ondansetron Hydrochloride | Novartis Pharms Corp | Accord Healthcare |
| 7/13/2015 | Tobi | Tobramycin | Novartis Pharms | Amneal Pharms |
| 7/14/2015 | Angiomax | Bivalirudin | Medicines Co | Hospira |
| 7/14/2015 | Angiomax | Bivalirudin | Medicines Co | Hospira |
| 7/14/2015 | Protonix IV | Pantoprazole Sodium | Wyeth | Sandoz |
| 7/15/2015 | Qualaquin | Quinine Sulfate | Mutual Pharm Co | Amneal Pharms |
| 7/15/2015 | Prandimet | Repaglinide / Metformin Hydrochloride | Novo Nordisk | Lupin |
| 7/16/2015 | Zyvox | Linezolid | Pharmacia and Upjohn | Sandoz |
| 7/20/2015 | Bimatoprost | Bimatoprost | Lupin | Apotex |
| 7/21/2015 | Sodium Fluoride F-18 | Sodium Fluoride F-18 | Houston Cyclotron | MIPS CRF |
| 7/22/2015 | Qualaquin | Quinine Sulfate | Mutual Pharm Co | RiconPharma |
| 7/23/2015 | Norvasc | Amlodipine Besylate | Pfizer | Sovereign Pharms |
| 7/23/2015 | Brevibloc | Esmolol Hydrochloride | Baxter Healthcare | Aurobindo Pharma |
| 7/24/2015 | Abilify | Aripiprazole | Otsuka | Apotex |
| 7/24/2015 | Diflorasone Diacetate | Diflorasone Diacetate | Taro | VersaPharm |
| 7/24/2015 | Niaspan | Niacin | Abbvie | Amneal Pharms |
| 7/24/2015 | Nimodipine | Nimodipine | Bannar Life Sciences | Sofgen Pharms |
| 7/27/2015 | Lithobid | Lithium Carbonate | Ani Pharms | Unique Pharm Labs |
| 7/28/2015 | Astelin | Azelastine Hydrochloride | Meda Pharms | Breckenridge Pharms |
| 7/28/2015 | Buprenex | Buprenorphine Hydrochloride | Indivior | Par Sterile Products |
| 7/28/2015 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Feinstein | University of Michigan |
| 7/28/2015 | Folic Acid | Folic Acid | Amneal Pharm/Watson Labs | Nuvo Pharm |
| 7/29/2015 | Edecrin | Ethacrynate Sodium | Aton | Par Sterile Products |
| 7/29/2015 | Sodium Fluoride F-18 | Sodium Fluoride F-18 | Houston Cyclotron | Hot Shots NM |
| 7/30/2015 | Benzonatate | Benzonatate | The Pharma Network | Strides Arcolab |
| 7/30/2015 | Prilosec OTC | Omeprazole Magnesium | Astrazeneca | Perrigo |
| 7/30/2015 | Sodium Fluoride F-18 | Sodium Fluoride F-18 | Houston Cyclotron | Cardnal Health 414 |
| 7/31/2015 | Benzonatate | Benzonatate | The Pharma Network | CSPC NBP Pharm |
| 7/31/2015 | Claritin | Loratadine | Bayer Healhcare | Taro |
| 7/31/2015 | Namenda | Memantine Hydrochloride | Forest Labs | Upsher Smith |
| 7/31/2015 | Aciphex | Rabeprazole Sodium | Eisai | Amneal Pharms |
| 8/3/2015 | Xanax | Alprazolam | Pharmacia and Upjohn | Aurobindo Pharma |
| 8/3/2015 | Nexium | Esomeprazole Magnesium | Astrazeneca | Mylan Labs |
| 8/3/2015 | Zutripro | Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride | Cypress Pharm | Coastal Pharms |
| 8/3/2015 | Advil | Ibuprofen Sodium | Pfizer Consumer Healthcare | Perrigo |
| 8/3/2015 | Singulair | Montelukast Sodium | Merck | Ajanta Pharma |
| 8/3/2015 | Singulair | Montelukast Sodium | Merck | Ajanta Pharma |
| 8/3/2015 | Singulair | Montelukast Sodium | Merck | Ajanta Pharma |
| 8/3/2015 | Invega | Paliperidone | Janssen Pharms | Actavis |
| 8/4/2015 | Androgel | Testosterone | Abbvie | Perrigo Israel |
| 8/4/2015 | Tindamax | Tinidazole | Mission Pharma | Edenbridge Pharms |
| 8/5/2015 | Zyrtec | Cetirizine Hydrochloride | McNeil Consumer | Aurobindo Pharma |
| 8/5/2015 | Zyrtec | Cetirizine Hydrochloride | McNeil Consumer | Aurobindo Pharma |
| 8/5/2015 | Precedex | Dexmethylphenidate Hydrochloride | Hospira | Watson Labs |
| 8/5/2015 | Fortesta | Testosterone | Endo Pharms | Actavis |
| 8/7/2015 | Amiloride Hydrochloride | Amiloride Hydrochloride | Par Pharm | Zydus Pharms USA |
| 8/7/2015 | Lidocaine | Lidocaine | Fougera | Amneal Pharms |
| 8/7/2015 | Lidoderm | Lidocaine | Teikoku Pharma USA | Mylan Technologies |
| 8/7/2015 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Dr. Reddy's |
| 8/11/2015 | Detrol LA | Tolterodine Tartrate | Pharmacia and Upjohn | Torrent Pharms |
| 8/12/2015 | Kariva | Bekyree | Barr | Lupin |
| 8/12/2015 | Ortho-Cept | Isibloom | Janssen Pharms | Sandoz |
| 8/12/2015 | Levaquin | Levofloxacin | Janssen Pharms | Hospira |
| 8/12/2015 | Cozaar | Lorsartan Potassium | Merck Sharp Dohme | Hetero Labs |
| 8/13/2015 | Keppra | Levetiracetam | UCB | Fresenius Kabi USA |
| 8/13/2015 | Atralin | Tretinoin | Dow Pharm | Spear Pharms |
| 8/14/2015 | Ammonia N 12 | Ammonia N 13 | Feinstein | Precision Nuclear |
| 8/14/2015 | Abilify | Aripiprazole | Otsuka | Amneal Pharms |
| 8/14/2015 | Abilify | Aripiprazole | Otsuka | Silarx Pharms |
| 8/14/2015 | Xylocaine | Lidocaine Hydrochloride | Fresenius Kabi USA | Luitpold |
| 8/14/2015 | Methylin | Methylphenidate Hydrochloride | Mallinckrodt | Novel Labs |
| 8/17/2015 | Yaz | Drospirenone / Ethinyl Estradiol | Bayer Healthcare | Glenmark Pharms |
| 8/17/2015 | Fenofibrate | Fenofibrate | Teva | Lupin |
| 8/17/2015 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lehigh Valley | Avanthi |
| 8/17/2015 | Xenazine | Tetrabenazine | Valeant | Sun Pharma Global |
| 8/18/2015 | Cisplatin | Cisplatin | Fresenius Kabi USA | Accord Healthcare |
| 8/18/2015 | Demeclocycline Hydrochloride | Demeclocycline Hydrochloride | Amneal Pharm | Epic Pharma |
| 8/18/2015 | Dolophine Hydrochloride | Methadone Hydrochloride | Roxane | Corepharma |
| 8/18/2015 | Sodium Fluoride F-18 | Sodium Fluoride F-18 | Houston Cyclotron | IBA Molecular N Am |
| 8/19/2015 | Boniva | Ibandronate Sodium | Roche | Lupin |
| 8/19/2015 | Prilosec | Omeprazole | Astrazeneca | Aurobindo Pharma USA |
| 8/20/2015 | Pennsaid | Diclofenac Sodium | Nuvo Research | Lupin |
| 8/20/2015 | Rozerem | Ramelteon | Takeda Pharms USA | Actavis |
| 8/21/2015 | Celebrex | Celecoxib | GD Searle | Alembic Pharms |
| 8/24/2015 | Delalutin | Hydroxyprogesterone Caproate | Bristol-Myers Squibb | McGuff |
| 8/24/2015 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lehigh Valley | Novel Labs |
| 8/24/2015 | Rythmol SR | Propafenone Hydrochloride | GlaxoSmithKline | Watson Labs |
| 8/25/2015 | Focalin XR | Dexmethylphenidate Hydrochloride | Novartis | Mylan Pharms |
| 8/25/2015 | Prilosec | Omeprazole | Astrazeneca | Lupin |
| 8/26/2015 | Baraclude | Entecavir | Bristol-Myers Squibb | Aurobindo Pharma |
| 8/26/2015 | Prometh VC | Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codiene Phosphate | Actavis | Amneal Pharms |
| 8/28/2015 | Tarceva | Erlotinib Hydrochloride | OSI Pharms | Teva Pharms USA |
| 8/28/2015 | Lexapro | Escitalopram Oxalate | Forest Labs | Prinston |
| 8/28/2015 | Evista | Raloxifene Hydrochloride | Eli Lilly | Aurobindo Pharma |
| 8/31/2015 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Feinstein | IBA Molecular N Am |
| 8/31/2015 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Feinstein | Queen Hamamatsu Pet |
| 8/31/2015 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Reckitt Benckiser | Actavis |
| 8/31/2015 | Dolophine Hydrochloride | Methadone Hydrochloride | Roxane | Aurolife Pharma |
| 8/31/2015 | Avelox | Moxifloxacin Hydrochloride | Bayer Healthcare | Mylan Pharms |
| 8/31/2015 | Detrol | Tolterodine Tartrate | Pharmacia and Upjohn | MacLeods Pharms |
| 9/2/2015 | Zyrtec | Cetirizine Hydrochloride | McNeil Consumer | Par Pharm |
| 9/2/2015 | Synalar | Fluocinolone Acetonide | Medimetriks Pharms | Gavis Pharms |
| 9/2/2015 | Vfend | Voriconazole | PF Prism CV | Glenmark Pharms |
| 9/3/2015 | Mucinex | Guaifenesin | Reckitt Benckiser | Actavis |
| 9/3/2015 | Levaquin | Levofloxacin in Dextrose 5% in Plastic Container | Janssen Pharms | Hospira |
| 9/3/2015 | Exelon | Rivastigmine | Novartis | Alvogen |
| 9/3/2015 | Micardis | Telmisartan | Boehringer Ingelheim | Aurobindo Pharma |
| 9/4/2015 | Ampicillin Sodium | Ampicillin Sodium | Sandoz | Hospira |
| 9/4/2015 | Ampicillin Sodium | Ampicillin Sodium | Sandoz | Hospira |
| 9/4/2015 | Topicort | Desoximetasone | Taro | Actavis |
| 9/4/2015 | Keppra XR | Levetiracetam | UCB | Dexcel Pharma |
| 9/4/2015 | Namenda | Memantine Hydrochloride | Forest Labs | Wockhardt |
| 9/4/2015 | Singulair | Montelukast Sodium | Merck | Amneal Pharms |
| 9/8/2015 | Giazo | Balsalazide Disodium | Valeant | Par Pharm |
| 9/8/2015 | Micardis | Telmisartan | Boehringer Ingelheim | Amneal Pharms |
| 9/9/2015 | Ortho Tri-Cyclenlo | Norgestimate / Ethinyl Estradiol | Janssen Pharms | Jai Pharma |
| 9/9/2015 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA / Hospira | Xellia Pharms |
| 9/10/2015 | Soriatane | Acitretin | Stiefel Labs Inc | Mylan Pharms |
| 9/8/2015 | Giazo | Balsalazide Disodium | Valeant | Par Pharm |
| 9/8/2015 | Micardis | Telmisartan | Boehringer Ingelheim | Amneal Pharms |
| 9/9/2015 | Ortho Tri-Cyclenlo | Norgestimate / Ethinyl Estradiol | Janssen Pharms | Jai Pharma |
| 9/9/2015 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA / Hospira | Xellia Pharms |
| 9/10/2015 | Soriatane | Acitretin | Stiefel Labs Inc | Mylan Pharms |
| 9/11/2015 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Feinstein | MIPS CRF |
| 9/11/2015 | Lescol XL | Fluvastatin Sodium | Novartis | Mylan Pharms |
| 9/15/2015 | Clarithromycin | Clarithromycin | Teva | Lupin |
| 9/15/2015 | Fazaclo ODT | Clozapine | Jazz Pharms | Mylan Pharms |
| 9/15/2015 | Ibuprofen | Ibuprofen | Dr Reddy's | Granules India |
| 9/15/2015 | Mestinon | Pyridostigmine Bromide | Valeant | Impax Labs |
| 9/16/2015 | Taxotere | Docetaxel | Sanofi Aventis | Teva Pharms USA |
| 9/16/2015 | Allegra | Fexofenadine Hydrochloride | Sanofi Aventis | Sciegen Pharms |
| 9/16/2015 | Allegra | Fexofenadine Hydrochloride | Sanofi Aventis | Sciegen Pharms |
| 9/16/2015 | Lopid | Gemfibrozil | Pfizer Pharms | Aurobindo Pharma |
| 9/16/2015 | Corgard | Nadolol | King Pharms | Orion Corp |
| 9/17/2015 | Zomig-ZMT | Zolmitriptan | Astrazeneca | Jubilant Generics |
| 9/18/2015 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva | Emcure Pharms USA |
| 9/18/2015 | Precedex | Dexmedetomidine Hydrochloride | Hospira | Fresenius Kabi USA |
| 9/21/2015 | Benzaclin | Clindamycin Phosphate / Benzoyl Peroxide | Valeant | Perrigo Israel |
| 9/21/2015 | Benzamycin | Erythromycin / Benzoyl Peroxide | Valeant | Lyne |
| 9/21/2015 | Nexium | Esomeprazole Magnesium | Astrazeneca | Hetero Labs |
| 9/21/2015 | Testred | Methyltestosterone | Valeant | Impax Labs |
| 9/21/2015 | Lysteda | Tranexamic Acid | Ferring Pharms | Mylan |
| 9/22/2015 | Cafcit | Caffeine Citrate | Eurohealth Intl | Aurobindo Pharma |
| 9/22/2015 | Ritalin | Methylphenidate Hydrochloride | Novartis | Ascent Pharms |
| 9/22/2015 | Roxicodone | Oxycodone Hydrochloride | Mallinckrodt | Epic Pharma |
| 9/23/2015 | Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | Ivax Sub Teva Pharms | Mirror Pharms |
| 9/24/2015 | Focalin | Dexmethylphenidate Hydrochloride | Novartis | Sun Pharm Inds |
| 9/25/2015 | Nexium | Esomeprazole Magnesium | Astrazeneca | Dr. Reddy's |
| 9/25/2015 | Nexium | Esomeprazole Sodium | Astrazeneca | Accord Healthcare |
| 9/29/2015 | Metadate CD | Methylphenidate Hydrochloride | UCB | Mallinckrodt |
| 9/30/2015 | Epiduo | Adapalene / Benzoyl Peroxide | Galderma Labs | Actavis |
| 9/30/2015 | Abilify | Aripiprazole | Otsuka | Apotex |
| 9/30/2015 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Prosphate | Luitpold | BD RX |
| 9/30/2015 | Zomig | Zolmitriptan | IPR | MacLeods Pharms |
| 9/30/2015 | Zomig | Zolmitriptan | IPR | Alembic Pharms |
