Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
10/3/2017 |
DDAVP |
Desmopressin Acetate |
Ferring |
Zydus Pharms |
10/3/2017 |
Copaxone |
Glatiramer Acetate |
Teva |
Mylan |
10/3/2017 |
Toviaz |
Fesoterodine Fumarate |
Pfizer |
Zydus Pharms |
10/3/2017 |
Copaxone |
Glatiramer Acetate |
Teva |
Mylan |
10/3/2017 |
Micardis |
Telmisartan |
Boehringer Ingelheim |
Micro Labs |
10/4/2017 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Zydus Pharms |
10/4/2017 |
Vigamox |
Moxifloxacin HCl |
Novartis |
Aurobindo |
10/5/2017 |
Effexor XR |
Venlafaxine HCl |
Wyeth |
MacLeods |
10/5/2017 |
Corgard |
Nadolol |
US Worldmeds |
Lupin |
10/6/2017 |
Actos |
Pioglitazone HCl |
Takeda |
Puracap Pharm |
10/6/2017 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
MacLeods |
10/6/2017 |
Acticlate |
Doxycyline Hyclate |
Aqua Pharms |
Amneal |
10/10/2017 |
Nuedexta |
Dextromethorphan Hydrobromide / Quinidine Sulfate |
Avanir Pharms |
Actavis |
10/10/2017 |
Cleocin |
Clindamycin Phosphate |
Pharmacia and Upjohn |
Mylan |
10/10/2017 |
Cleocin |
Clindamycin Phosphate |
Pharmacia and Upjohn |
Mylan |
10/10/2017 |
Baraclude |
Entecavir |
Bristol Myers Squibb |
Prinston |
10/11/2017 |
Pristiq |
Desvenlafaxine Succinate |
Wyeth |
Zydus Pharms |
10/11/2017 |
Mepron |
Atovaquone |
GlaxoSmithKline |
Apotex |
10/12/2017 |
Emend |
Aprepitant |
Merck |
Glenmark |
10/12/2017 |
Zyloprim |
Allopurinol |
Casper Pharma |
Zydus Pharms |
10/13/2017 |
Gabitril |
Tiagabine HCl |
Cephalon |
Wilshire Pharms |
10/13/2017 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Haupt Pharma |
10/13/2017 |
Tobi |
Tobramycin |
Novartis |
Mylan |
10/16/2017 |
Nitrostat |
Nitroglycerin |
Pfizer |
Actavis |
10/16/2017 |
Effient |
Prasugrel |
Eli Lilly and Co |
Liberty Pharma |
10/16/2017 |
Effient |
Prasugrel |
Eli Lilly and Co |
Aurobindo |
10/16/2017 |
Effient |
Prasugrel |
Eli Lilly and Co |
Panacea Biotec |
10/16/2017 |
Zemplar |
Paricalcitol |
AbbVie |
Akorn |
10/16/2017 |
Gastrocrom |
Cromolyn Sodium |
Mylan |
Ailex Pharms |
10/16/2017 |
Nexium 24Hr (OTC) |
Esomeprazole Magnesium (OTC) |
AstraZeneca |
Aurobindo |
10/16/2017 |
Aczone |
Dapsone |
Allergan |
Taro |
10/17/2017 |
Ancobon |
Flucytosine |
Valeant |
West-Ward |
10/18/2017 |
Bumex |
Bumetanide |
Validus Pharms |
Amneal |
10/20/2017 |
Lodosyn |
Carbidopa |
Aton |
Novel Labs |
10/20/2017 |
Prometrium |
Progesterone |
Virtus Pharms |
Sandoz |
10/20/2017 |
Nexium |
Esomeprazole Magnesium |
AstraZeneca |
Alkem Labs |
10/23/2017 |
Renvela |
Sevelamer Carbonate |
Genzyme |
Impax Labs |
10/23/2017 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Lupin |
10/23/2017 |
Klor-Con |
Potassium Chloride |
Pharma Res Software |
Upsher-Smith Labs |
10/25/2017 |
Coreg CR |
Carvedilol Phosphate |
SmithKline Beecham |
Sun Pharm Industries |
10/25/2017 |
Nexterone |
Amiodarone HCl |
Baxter Healthcare |
Aurobindo |
10/25/2017 |
Levetiracetam in Sodium Chloride |
Levetiracetam in Sodium Chloride |
HQ Specialty Pharma |
Gland Pharma |
10/26/2017 |
Neurontin |
Gabapentin |
Pfizer |
Jiangsu Hengrui Med |
10/26/2017 |
Renvela |
Sevelamer Carbonate |
Genzyme |
Invagen Pharms |
10/26/2017 |
Neurontin |
Gabapentin |
Pfizer |
CSPC Ouyi Pharm |
10/27/2017 |
Reclast |
Zoledronic Acid |
Novartis |
Mylan |
10/27/2017 |
Methadone HCl |
Methadone HCl |
Mylan |
Akorn |
10/27/2017 |
Clobex |
Clobetasol Propionate |
Galderma Labs |
Hi-Tech Pharmacal |
10/27/2017 |
Zometa |
Zoledronic Acid |
Novartis |
Cipla |
10/27/2017 |
Dilaudid |
Hydromorphone HCl |
Rhodes |
Ascent Pharms |
10/30/2017 |
Azilect |
Rasagiline Mesylate |
Teva |
Alkem Labs |
10/30/2017 |
Xylocaine |
Lidocaine HCl |
Fresenius Kabi USA |
Aurobindo |
10/30/2017 |
Allegra-D |
Fexofenadine HCl / Pseudoephedrine HCl (OTC) |
Sanofi Aventis |
Aurobindo |
10/31/2017 |
Acetadote |
Acetylcysteine |
Cumberland Pharms |
Sagent Pharms |
10/31/2017 |
Glucophage |
Metformin HCl |
Bristol Myers Squibb |
MacLeods |
10/31/2017 |
Dexedrine |
Dextroamphetamine Sulfate |
Impax Labs |
Vintage Pharms |
10/31/2017 |
Boniva |
Ibandronate Sodium |
Hoffmann La Roche |
MacLeods |
10/31/2017 |
Tamiflu |
Oseltamivir Phosphate |
Roche |
Alvogen Pine Brook |
11/2/2017 |
Zemplar |
Paricalcitol |
AbbVie |
Mylan |
11/2/2017 |
Azor |
Amlodipine / Olmesartan Medoxomil |
Daiichi Sankyo |
Micro Labs |
11/3/2017 |
Wellbutrin XL |
Bupropion HCl |
Valeant |
TWi |
11/6/2017 |
Hyzaar |
Losartan Potassium / Hydrochlorothiazide |
Merck Sharp Dohme |
Prinston |
11/6/2017 |
Clolar |
Clofarabine |
Genzyme |
Dr Reddys Labs |
11/6/2017 |
Integrilin |
Eptifibatide |
Schering |
Accord Healthcare |
11/6/2017 |
Clolar |
Clofarabine |
Genzyme |
Amneal |
11/6/2017 |
Clolar |
Clofarabine |
Genzyme |
Mylan |
11/6/2017 |
Micardis HCT |
Telmisartan / Hydrochlorothiazide |
Boehringer Ingelheim |
Prinston |
11/8/2017 |
Motrin IB (OTC) |
Ibuprofen (OTC) |
Johnson and Johnson |
Aurobindo |
11/9/2017 |
Vigamox |
Moxifloxacin HCl |
Novartis |
Akorn |
11/9/2017 |
Cosmegen |
Dactinomycin |
Recordati Rare |
Mylan |
11/9/2017 |
Diprolene |
Betamethasone Dipropionate |
Merck Sharp Dohme |
Teligent Pharma |
11/9/2017 |
Children's Allegra |
Fexofenadine HCl |
Sanofi Aventis |
Taro Pharm |
11/9/2017 |
Children's Allegra |
Fexofenadine HCl |
Sanofi Aventis |
Taro Pharm |
11/9/2017 |
Oxycodone HCl |
Oxycodone HCl |
Lehigh Valley / Vistapharm |
Ascent Pharms |
11/13/2017 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Zhejiang Hisun Pharm |
11/13/2017 |
Zovirax |
Acyclovir |
Valeant |
G and W Labs |
11/13/2017 |
Zocor |
Simvastatin |
Merck Sharp Dohme |
Hisun Pharm Hangzhou |
11/13/2017 |
Zantac 150 (OTC) |
Ranitidine HCl (OTC) |
Sanofi |
Aurobindo |
11/13/2017 |
Zantac 75 (OTC) |
Ranitidine HCl (OTC) |
Sanofi |
Aurobindo |
11/14/2017 |
Eloxatin |
Oxaliplatin |
Sanofi Aventis / Teva |
Mylan |
11/16/2017 |
Solodyn |
Minocycline HCl |
Medicis |
Zydus Pharms |
11/16/2017 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Zhejiang Hisun Pharm |
11/16/2017 |
Lotrimin Ultra (OTC) |
Butenafine HCl (OTC) |
Bayer Healthcare |
Taro |
11/16/2017 |
Intuniv |
Guanfacine HCl |
Shire |
Sun Pharm Inds |
11/16/2017 |
Pulmicort |
Budesonide |
AstraZeneca |
Cipla |
11/16/2017 |
Dacogen |
Decitabine |
Otsuka |
Cipla |
11/16/2017 |
Fluoxetine HCl |
Fluoxetine HCl |
Alvogen |
Par |
11/17/2017 |
Cytovene |
Ganciclovir |
Roche Palo |
Mylan |
11/17/2017 |
Loestrin 24 Fe |
Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate |
Apil |
Glenmark |
11/17/2017 |
Abstral |
Fentanyl Citrate |
Sentynl Theraps |
Actavis |
11/17/2017 |
Edecrin |
Ethacrynate Sodium |
Aton |
Zydus Pharms |
11/20/2017 |
Choline C-11 |
Choline C-11 |
MCPRF |
UCSF Rodiopharm |
11/20/2017 |
Busulfex |
Myleran |
Otsuka |
Aspen Global |
11/20/2017 |
Focalin |
Dexmethylphenidate HCl |
Novartis |
Rhodes |
11/20/2017 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Ajanta |
11/20/2017 |
Fluoxetine HCl |
Fluoxetine HCl |
Alvogen |
Inventia Healthcare |
11/20/2017 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Xiamen LP Pharm |
11/20/2017 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Amneal |
11/21/2017 |
Ziagen |
Abacavir Sulfate |
VIIV Healthcare |
Cipla |
11/21/2017 |
Prezista |
Darunavir Ethanolate |
Janssen |
Teva |
11/21/2017 |
Loestrin Fe 1/20 |
Hailey Fe 1/20 |
Apil |
Glenmark |
11/21/2017 |
Vytorin |
Ezetimibe and Simvastatin |
Merck Sharp Dohme |
Amneal |
11/21/2017 |
Locoid |
Hydrocortisone Butyrate |
Precision Dermat |
Teligent Pharma |
11/21/2017 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Humanwell Puracap |
11/22/2017 |
Angiomax |
Bivalirudin |
The Medicines Co |
Accord Healthcare |
11/22/2017 |
Crestor |
Rosuvastatin Calcium |
IPR |
MSN Labs |
11/24/2017 |
Robaxin |
Methocarbamol |
West-Ward |
Navinta |
11/24/2017 |
Topotecan HCl |
Topotecan Hydrochloride |
Hospira |
Mylan |
11/24/2017 |
Trokendi XR |
Topiramate |
Supernus Pharms |
Zydus Pharms |
11/24/2017 |
Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container |
Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container |
Hospira / B Braun & Baxter Healthcare & Hospira & ICU Medical |
Fresenius Kabi USA |
11/27/2017 |
Capastat Sulfate |
Capreomycin Sulfate |
Akorn |
Mylan |
11/27/2017 |
Atacand HCT |
Candesartan Cilexetil and Hydrochlorothiazide |
AstraZeneca |
Zydus Pharms |
11/27/2017 |
Xeloda |
Capecitabine |
Hoffmann La Roche |
Alkem Labs |
11/27/2017 |
Biltricide |
Praziquantel |
Bayer Healthcare |
Par |
11/28/2017 |
Depo-Provera |
Medroxyprogesterone Acetate |
Pharmacia and Upjohn |
Amphastar Pharms |
11/28/2017 |
Depo-Provera |
Medroxyprogesterone Acetate |
Pharmacia and Upjohn |
Amphastar Pharms |
11/28/2017 |
Precedex |
Dexmedetomidine Hydrochloride |
Hospira |
Teva |
11/28/2017 |
Renvela |
Sevelamer Carbonate |
Genzyme |
Amneal |
11/29/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
MacLeods |
11/29/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
Accord Healthcare |
11/29/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
Aurobindo |
11/29/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
Novast Labs |
11/29/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
Sciegen Pharms |
11/30/2017 |
Remodulin |
Treprostinil |
United Therap |
Sandoz |
11/30/2017 |
Zantac 150 / Zantac 300 |
Ranitidine Hydrochloride |
Glaxo Grp |
Acic Pharms |
11/30/2017 |
Heparin Sodium |
Heparin Sodium |
Fresenius Kabi USA & West-Ward |
Mylan |
11/30/2017 |
Heparin Sodium |
Heparin Sodium |
Fresenius Kabi USA |
Mylan |
11/30/2017 |
Prograf |
Tacrolimus |
Astellas |
Belcher Pharms |
12/1/2017 |
Seroquel XR |
Quetiapine Fumarate |
AstraZeneca |
Anchen Pharms |
12/1/2017 |
Megace ES |
Megestrol Acetate |
Endo |
Breckenridge |
12/1/2017 |
Advil Cold and Sinus (OTC) |
Ibuprofen and Pseudoephedrine Hydrochloride (OTC) |
Pfizer |
Aurobindo |
12/4/2017 |
Abilify |
Aripiprazole |
Otsuka |
Prinston |
12/5/2017 |
Pataday |
Olopatadine Hydrochloride |
Novartis |
Apotex |
12/5/2017 |
Pataday |
Olopatadine Hydrochloride |
Novartis |
Akorn |
12/5/2017 |
Pataday |
Olopatadine Hydrochloride |
Novartis |
Cipla |
12/6/2017 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Mylan |
12/6/2017 |
Gemcitabine HCl |
Gemcitabine HCl |
Hospira |
Mylan |
12/6/2017 |
Magnesium Sulfate in Plastic Container |
Magnesium Sulfate in Plastic Container |
Hospira |
HQ Specialty Pharma |
12/6/2017 |
Diclegis |
Doxylamine Succinate and Pyridoxine Hydrochloride |
Duchesnay |
Par |
12/6/2017 |
Clozaril |
Clozapine |
Heritage Life |
Zydus Pharms |
12/6/2017 |
Clolar |
Clofarabine |
Genzyme |
MSN Labs |
12/8/2017 |
Melphalan HCl |
Melphalan HCl |
Dr Reddys Labs |
Dr Reddys Labs |
12/8/2017 |
Locoid Lipocream |
Hydrocortisone Butyrate |
Precision Dermat |
Actavis |
12/8/2017 |
Busulfex |
Busulfan |
Otsuka |
Actavis |
12/8/2017 |
Cytovene |
Ganciclovir Sodium |
Roche Palo |
Pharmascience |
12/8/2017 |
Enablex |
Darifenacin Hydrobromide |
Apil |
Alembic |
12/8/2017 |
Gabitril |
Tiagabine Hydrochloride |
Cephalon |
Amneal |
12/8/2017 |
Reclast |
Zoledronic Acid |
Novartis |
Aurobindo |
12/11/2017 |
Kenalog-40 |
Triamcinolone Acetonide |
Apothecon |
Amneal |
12/12/2017 |
Mirapex ER |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Zydus Pharms |
12/12/2017 |
Macrodantin |
Nitrofurantoin |
Alvogen Malta |
Zydus Pharms |
12/12/2017 |
Safyral |
Tydemy |
Bayer Healthcare |
Lupin |
12/12/2017 |
Detrol LA |
Tolterodine Tartrate |
Pharmacia and Upjohn |
Hetero Labs |
12/12/2017 |
Valcyte |
Valganciclovir Hydrochloride |
Hoffmann La Roche |
Dr Reddys Labs |
12/12/2017 |
Flagyl |
Metronidazole |
GD Searle |
Cadila Pharms |
12/14/2017 |
Cafcit |
Caffeine Citrate |
West-Ward |
Micro Labs |
12/14/2017 |
Inapsine |
Droperidol |
Akorn |
Eurohealth Intl |
12/15/2017 |
Sustiva |
Efavirenz |
Bristol Myers Squibb |
Aurobindo |
12/15/2017 |
Duac |
Clindamycin Phosphate / Benzoyl Peroxide |
Stiefel |
Taro |
12/15/2017 |
Astepro |
Azelastine HCl |
Mylan |
Amneal |
12/18/2017 |
Mesnex |
Mesna |
Baxter Healthcare |
Gland Pharma |
12/18/2017 |
Xenazine |
Tetrabenazine |
Valeant |
Bionpharma |
12/18/2017 |
Busulfex |
Busulfan |
Otsuka |
Amneal |
12/19/2017 |
Exforge HCT |
Amlodipine Besylate / Valsartan / Hydrochlorothiazide |
Novartis |
Aurobindo |
12/19/2017 |
Procardia XL |
Nifedipine |
Pfizer |
Zydus Pharms |
12/21/2017 |
Advil Liqui-Gels |
Ibuprofen (OTC) |
Pfizer |
Ascent Pharms |
12/21/2017 |
Zetia |
Ezetimibe |
Merck Sharp Dohme |
Alkem Labs |
12/22/2017 |
Melphalan HCl |
Melphalan HCl |
Dr Reddys Labs |
Fresenius Kabi USA |
12/22/2017 |
Ativan |
Lorazepam |
Valeant Intl |
Aurolife Pharma |
12/22/2017 |
Avage / Tazorac |
Tazarotene |
Allergan |
G and W Labs |
12/22/2017 |
Vytorin |
Ezetimibe / Simvastatin |
Merck Sharp Dohme |
Alkem Labs |
12/22/2017 |
Zyrtec |
Cetirizine HCl |
Johnson and Johnson |
Granules India |
12/22/2017 |
Yaz |
Drospirenone / Ethinyl Estradiol |
Bayer Healthcare |
Cyndea Pharma |
12/22/2017 |
Methotrexate Sodium |
Methotrexate Sodium |
Dava Pharms |
Amneal |
12/26/2017 |
Fortamet |
Metformin HCl |
Andrx Labs |
Nostrum Labs |
12/26/2017 |
Norpramin |
Desipramine HCl |
US Pharm Holdings |
Ingenus Pharms |
12/26/2017 |
Arixtra |
Fondaparinux Sodium |
Mylan |
Aurobindo |
12/26/2017 |
Triamcinolone Acetonide |
Triamcinolone Acetonide |
Mylan |
Alkem Labs |
12/26/2017 |
Synalar |
Fluocinolone Acetonide |
Medimetriks Pharms |
Glasshouse Pharms |
12/26/2017 |
Minastrin 24 Fe |
Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate |
Apil |
Glenmark |
12/27/2017 |
Seasonique |
Jaimiess |
Teva |
Labs Leon Farma |
12/27/2017 |
Anafranil |
Clomipramine HCl |
Mallinckrodt |
Zydus Pharms |
12/29/2017 |
Valtrex |
Valacyclovir HCl |
GlaxoSmithKline |
Zydus Pharms |
12/29/2017 |
Feldene / Piroxicam |
Piroxicam |
Pfizer / Micro Labs |
Micro Labs |
12/29/2017 |
Zometa |
Zoledronic Acid |
Novartis |
BPI Labs |
12/29/2017 |
Mucinex D (OTC) |
Guaifenesin, Pseudoephedrine HCl (OTC) |
Reckitt Benckiser |
Dr Reddys Labs |