Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
10/5/2015 |
Indomethacin |
Indomethacin |
Sandoz |
Jubilant Generics |
10/7/2015 |
Trilipix |
Fenofibric Acid |
Abbvie |
Actavis Elizabeth |
10/7/2015 |
Ketorolac Tromethamine |
Ketorolac Tromethamine |
Hospira |
BD RX |
10/8/2015 |
Abilify |
Aripiprazole |
Otsuka |
Aurobindo Pharma |
10/8/2015 |
Singulair |
Montelukast Sodium |
Merck |
Unichem Labs |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Jubilant Generics |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Unichem Labs |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Torrent Pharms |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Alembic Pharms |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
MacLeods Pharms |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
MacLeods Pharms |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Aurobindo Pharma |
10/13/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Silarx Pharms |
10/13/2015 |
Aloxi |
Palonosetron Hydrochloride |
Helsinn Healthcare |
Teva |
10/13/2015 |
Aloxi |
Palonosetron Hydrochloride |
Helsinn Healthcare |
Sandoz |
10/14/2015 |
Cozaar |
Losartan Potassium |
Merck Sharp & Dohme |
Unichem Labs |
10/15/2015 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
Cipla |
10/16/2015 |
Maxalt T-MLT |
Rizatriptan Benzoate |
Merck |
Jubilant Generics |
10/16/2015 |
Boniva |
Ibandronate Sodium |
Roche |
Apotex |
10/16/2015 |
Buprenorphine Hydrochloride / Naloxone Hydrochloride |
Buprenorphine Hydrochloride / Naloxone Hydrochloride |
Actavis Elizabeth |
Ethypharm USA |
10/19/2015 |
Nexium |
Esomeprazole Magnesium |
AstraZeneca |
Torrent Pharms |
10/19/2015 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
3D Imaging Drug |
10/19/2015 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
3D Imaging Drug |
10/20/2015 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
Sagent Pharms |
10/20/2015 |
Intuniv |
Guanfacine Hydrochloride |
Shire |
Impax Labs |
10/20/2015 |
Zyprexa |
Olanzapine |
Lilly |
Alkem Labs |
10/20/2015 |
Levoleucovorin Calcum |
Levoleucovorin Calcium |
Sandoz |
Mylan |
10/20/2015 |
Ultram ER |
Tramadol Hydrochloride |
Valeant |
Aurobindo Pharma |
10/21/2015 |
Modicon 28 |
Norethindrone / Ethinyl Estradiol |
Janssen Pharms |
Jai Pharma |
10/21/2015 |
Ortho-Novum 1/35-28 |
Norethindrone / Ethinyl Estradiol |
Janssen Pharms |
Jai Pharma |
10/22/2015 |
Yaz |
Drospirenone / Ethinyl Estradiol |
Bayer Healthcare |
Jai Pharma |
10/22/2015 |
Aricept |
Donepezil Hydrochloride |
Eisai |
Mylan |
10/22/2015 |
Zomig-ZMT |
Zolmitriptan |
AstraZeneca |
MacLeods Pharms |
10/23/2015 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
Triad Isotopes |
10/26/2015 |
Phoslo Gelcaps |
Calcium Acetate |
Fresenius Medical |
Nostrum Labs |
10/27/2015 |
Ortho Cyclen-28 |
Norgestimate / Ethinyl Estradiol |
Janssen Pharms |
Haupt Pharma |
10/27/2015 |
Lamictal ODT |
Lamotrigine |
GlaxoSmithKline |
Par Pharm |
10/27/2015 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
UCLA Biomedical |
Kettering MedCtr |
10/28/2015 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Anchen Pharms |
10/28/2015 |
Blisovi 24Â |
FENorethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate |
Amneal Pharms |
Lupin |
10/28/2015 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Inventia Healthcare |
10/29/2015 |
Choline C-11 |
Choline C-11 |
MCPRF |
Univ TX MD Anderson |
10/30/2015 |
Aricept |
Donepezil Hydrochloride |
Eisai |
Lupin |
10/30/2015 |
Lotrisone |
Clotrimazole / Betamethasone Dipropionate |
Merck Sharp & Dohme |
Glenmark Pharms |
10/30/2015 |
Fiorinal w/Codeine |
Butalbital / Aspirin / Caffeine / Codeine Phosphate |
Actavis Labs UT |
Coastal Pharms |
10/30/2015 |
Butapap |
Butalbital / Acetaminophen |
Mikart |
Tedor Pharma |
10/30/2015 |
Micardis |
Telmisartan |
Boehringer Ingelheim |
Inventia Healthcare |
10/30/2015 |
Sporanox |
Itraconazole |
Janssen Pharms |
Amneal Pharms |
11/2/2015 |
Micardis HCT |
Telmisartan / Hydrochlorothiazide |
Boehringer Ingelheim |
MacLeods Pharms |
11/3/2015 |
Ultane |
Sevoflurane |
Abbvie |
Shanghai Hengrui |
11/4/2015 |
Felbatol |
Felbamate |
Meda Pharms |
Corepharma |
11/5/2015 |
Actoplus Met |
Pioglitazone Hydrochloride / Metformin Hydrochloride |
Takeda |
MacLeods Pharms |
11/5/2015 |
Singulair |
Montelukast Sodium |
Merck |
Anbison Lab |
11/5/2015 |
Klor-Con |
Potassium Chloride |
Upsher-Smith Labs |
Paddock |
11/9/2015 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
Alvogen Malta |
11/9/2015 |
Axert |
Almotriptan Malate |
Janssen Pharms |
Mylan |
11/10/2015 |
Dextroamp Saccharate / AMP Aspartate / AMP Sulfate |
Dextroamp Saccharate / AMP Aspartate / AMP Sulfate |
Barr |
Mylan |
11/12/2015 |
Ortho Tri-Cyclen |
Norgestimate / Ethinyl Estradiol |
Janssen Pharms |
Haupt Pharma |
11/12/2015 |
Soma |
Carisoprodol |
Meda Pharms |
Shasun Pharms |
11/12/2015 |
Baraclude |
Entecavir |
Bristol Myers Squibb |
Amneal Pharms |
11/13/2015 |
NTEs |
Fludeoxyglucose F18 |
|
Cardinal Health 414 |
11/13/2015 |
Seasonale |
Levonorgestrel / Ethinyl Estradiol |
Teva Branded Pharm |
Haupt Pharma |
11/13/2015 |
Choline C-11 |
Choline C-11 |
MCPRF |
Global Isotopes |
11/13/2015 |
Ritalin |
Methylphenidate Hydrochloride |
Novartis |
Novel Labs |
11/16/2015 |
Voltaren |
Diclofenac Sodium |
Novartis |
Altaire Pharms |
11/17/2015 |
Desoxyn |
Methamphetamine Hydrochloride |
Recordati Rare |
Roxane |
11/17/2015 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
Midwest Medical |
11/17/2015 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
UIHC Pet Imaging |
11/17/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Puracap Pharm |
11/18/2015 |
Loestrin FE 1.5/30 |
Blisovi FE 1.5/30 |
Warner Chilcott |
Lupin |
11/18/2015 |
Revatio |
Sildenafil Citrate |
Pfizer |
Aurobindo Pharma |
11/18/2015 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Breckenridge Pharm |
11/19/2015 |
Trivora-28 |
Levonorgestrel / Ethinyl Estradiol |
Watson Labs |
Lupin |
11/19/2015 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Midwest Medical |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Banner Pharmacaps |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Vintage Pharms LLC |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Rising Pharms Inc |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Sandoz |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Actavis Labs FL |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Amneal Pharms |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Strides Arcolab |
11/20/2015 |
Avodart |
Dutasteride |
GlaxoSmtihKline |
Breckenridge Pharm |
11/20/2015 |
Jalyn |
Dutasteride / Tamsulosin Hydrochloride |
GlaxoSmithKline |
Actavis Labs FL |
11/23/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Roxane |
11/23/2015 |
Ditropan XL |
Oxybutynin Chloride |
Janssen Pharms |
Amneal Pharms |
11/23/2015 |
Embeline |
Clobetasol Propionate |
Hi Tech Pharma |
Novel Labs |
11/24/2015 |
Dextroamphetamine Sulfate |
Dextroamphetamine Sulfate |
Barr |
Avanthi |
11/24/2015 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Apotex |
11/24/2015 |
Canasa |
Mesalamine |
Forest Labs |
Mylan |
11/24/2015 |
Fazaclo ODT |
Clozapine |
Jazz Pharms |
Barr Labs |
11/25/2015 |
Clozaril |
Clozapine |
Heritage Life |
Accord Healthcare |
11/27/2015 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
Sagent Pharms |
11/27/2015 |
Paxil |
Paroxetine Hydrochloride |
Apotex |
Jubilant Generics |
11/30/2015 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Apotex |
11/30/2015 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Sun Pharma Global |
11/30/2015 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Aurobindo Pharma |
11/30/2015 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Mylan |
11/30/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Ajanta Pharma |
12/1/2015 |
Dexamethasone Sodium Phosphate |
Dexamethasone Sodium Phosphate |
Luitpold |
Aurobindo Pharma |
12/2/2015 |
Solaraze |
Diclofenac Sodium |
Fougera Pharms |
Actavis Mid Atlantic |
12/3/2015 |
Gleevec |
Imatinib Mesylate |
Novartis |
Sun Pharma |
12/4/2015 |
Trivora-28 |
Elifemme |
Watson Labs |
Sandoz |
12/4/2015 |
Butapap |
Butalbital / Acetaminophen |
Mikart |
Larken Labs |
12/4/2015 |
Focalin |
Dexmethylphenidate Hydrochloride |
Novartis |
Novel Labs |
12/4/2015 |
Focalin |
Demethylphenidate Hydrochloride |
Novaris |
Abhai |
12/7/2015 |
Patanol |
Olopatadine Hydrochloride |
Alcon |
Apotex |
12/7/2015 |
Unasyn |
Ampicillin / Sulbactam |
Pfizer |
Antibiotics SA |
12/7/2015 |
Avapro |
Irbesartan |
Sanofi Aventis |
Unichem Labs |
12/7/2015 |
Patanol |
Olopatadine Hydrochloride |
Alcon |
USV North America |
12/7/2015 |
Patanol |
Olopatadine Hydrochloride |
Alcon |
Zach System Spa |
12/7/2015 |
Avapro |
Irbesartan |
Sanofi Aventis |
Sciegen Pharms |
12/7/2015 |
Levothyroxine Sodium |
Levothyroxine Sodium |
Fresenius Kabi USA |
Par Sterile Products |
12/7/2015 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Bio-Pharm |
12/7/2015 |
Patanol |
Olopatadine Hydrochloride |
Alcon |
Novel Labs |
12/8/2015 |
Potassium Chloride |
Potassium Chloride |
Actavis Labs FL |
Pharmaceutics Int'l |
12/8/2015 |
Integrilin |
Eptifibatide |
Schering |
Aurobindo Pharma |
12/8/2015 |
Plan B One-Step (OTC) |
Athentia Next (OTC) |
Teva Branded Pharm |
Aurobindo Pharma |
12/9/2015 |
Amikacin Sulfate |
Amikacin Sulfate |
Eurohealth Intl |
Fresenius Kabi USA |
12/9/2015 |
Amikacin Sulfate |
Amikacin Sulfate |
Eurohealth Intl |
Fresenius Kabi USA |
12/9/2015 |
Pennsaid |
Diclofenac Sodium |
Nuvo Res |
Novel Labs |
12/9/2015 |
Cyclogyl |
Cyclopentolate Hydrochloride |
Alcon |
Akorn |
12/10/2015 |
Imitrex Statdose |
Sumatriptan Succinate |
GlaxoSmithKline |
Antares Pharma |
12/10/2015 |
Avapro |
Irbesartan |
Sanofi Aventis |
Ajanta Pharma |
12/10/2015 |
Fyavolv |
Norethindrone Acetate / Ethinyl Estradiol |
Barr Labs |
Lupin |
12/10/2015 |
Toviaz |
Fesoterodine Fumarate |
Pfizer |
Alkem Labs |
12/10/2015 |
Norvasc |
Amlodipine Besylate |
Pfizer |
Ascent Pharms |
12/11/2015 |
Oxacillin Sodium |
Oxacillin Sodium |
Sandoz |
Hospira |
12/11/2015 |
Niaspan |
Niacin |
Abbvie |
Amneal Pharms |
12/11/2015 |
Starlix |
Nateglinide |
Novartis |
Alvogen Malta |
12/11/2015 |
Cyanocobalamin / Vibisone |
Cyanocobalamin / Vibisone |
Luitpold / Fresenius Kabi USA |
Gavis Pharms |
12/15/2015 |
Benzphetamine Hydrochloride |
Benzphetamine Hydrochloride |
KVK Tech |
Epic Pharma |
12/15/2015 |
Citalopram Hydrobromide |
Citalopram Hydrobromide |
Roxane |
Hetero Labs |
12/15/2015 |
Miralax (OTC) |
Polyethylene Glycol 3350 (OTC) |
Bayer Healthcare |
Ani Pharms |
12/15/2015 |
Imodium A-D (OTC) |
Loperamide Hydrochloride (OTC) |
J & J Consumer |
Aurobindo Pharma |
12/15/2015 |
Solu-Medrol |
Methylprednisolone Sodium Succinate |
Pharmacia and Upjohn |
Aurobindo Pharma |
12/16/2015 |
Buspirone Hydrochloride |
Buspirone Hydrochloride |
Teva |
Orion Corp Orion |
12/16/2015 |
Modicon 28 |
Cyclafem 0.5/35 |
Janssen Pharms |
Vintage Pharms |
12/16/2015 |
MS Contin |
Morphine Sulfate |
Purdue Pharma |
Novel Labs |
12/16/2015 |
Keppra |
Levetiracetam |
UCB |
Secan Pharms |
12/17/2015 |
Aricept |
Donepezil Hydrochloride |
Eisai |
Actavis Elizabeth |
12/17/2015 |
Kaitlib FEÂ |
Norethindrone / Ethinyl Estradiol / Ferrous Fumarate |
Warner Chilcott |
Lupin |
12/17/2015 |
Perphenazine |
Perphenazine |
Sandoz |
Indicus Pharma |
12/18/2015 |
Potassium Chloride |
Potassium Chloride |
Actavis Labs FL |
Lupin |
12/18/2015 |
Corgard |
Nadolol |
US World Meds |
Invagen Pharms |
12/18/2015 |
Patanol |
Olopatadine Hydrochloride |
Alcon |
Aurobindo Pharma |
12/18/2015 |
Merrem |
Meropenem |
AstraZeneca |
Daewoong Pharm |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Mylan |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Glenmark Pharms |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Hetero Labs |
12/21/2015 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Mylan |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Amneal Pharms |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Alembic Pharms |
12/21/2015 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Alkem Labs |
12/21/2015 |
Busulfex |
Busulfan |
Otsuka Pharm |
Pharmaforce |
12/22/2015 |
Ultram ER |
Tramadol Hydrochloride |
Valeant |
Mylan |
12/22/2015 |
Diprivan |
Propofol |
Fresenius Kabi USA |
Watson Labs |
12/22/2015 |
Pepcid |
Famotidine |
Valeant Pharms North |
Aurobindo Pharma |
12/23/2015 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA / Hospira |
Teva |
12/23/2015 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA / Hospira |
Teva |
12/23/2015 |
Soriatane |
Acitretin |
Stiefel Labs |
Watson Labs |
12/23/2015 |
Celexa |
Citalopram Hydrobromide |
Forest Labs |
Jubilant Generics |
12/23/2015 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA / Hospira |
Xellia Pharms |
12/23/2015 |
Neurontin |
Gabapentin |
Pfizer Pharms |
Alkem Labs |
12/23/2015 |
Celebrex |
Celecoxib |
GD Searle |
Torrent Pharms |
12/24/2015 |
Reclast |
Zoledronic Acid |
Novartis |
Apotex |
12/28/2015 |
Ortho-Novum 7/7/7-28 |
Norethindrone / Ethinyl Estradiol |
Janssen Pharms |
Jai Pharma |
12/28/2015 |
Cefazolin Sodium |
Cafezolin Sodium |
Hospira |
Qilu Pharm |
12/28/2015 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA / Hospira |
Custopharm |
12/28/2015 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA / Hospira |
Custopharm |
12/28/2015 |
Bloxiverz |
Neostigmine Methylsulfate |
Eclat Pharms |
Eurohealth Int'l |
12/29/2015 |
Potassium Acetate |
Potassium Acetate |
Hospira |
Exela Pharma SCS |
12/30/2015 |
Minocycline Hydrochloride |
Minocycline Hydrochloride |
Sandoz |
Sidmak Labs India |