| 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 |
Counsel
