Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
10/6/2016 |
Morphine Sulfate |
Morphine Sulfate |
Roxane |
Nostrum Labs |
10/6/2016 |
Virazole |
Ribavirin |
Valeant |
Navinta |
10/7/2016 |
Motrin IB (OTC) |
Ibuprofen (OTC) |
Johnson and Johnson Consumer |
Granules India Ltd |
10/7/2016 |
Abilify |
Aripiprazole |
Otsuka |
MacLeods |
10/7/2016 |
Paricalcitol |
Paricalcitol |
Teva |
Marksans Pharma |
10/11/2016 |
Safyral |
Drospirenone / Ethinyl Estradiol / Levomefolate Calcium |
Bayer Healthcare |
Watson Labs |
10/12/2016 |
Avalide |
Irbesartan / Hydrochlorothiazide |
Sanofi Aventis US |
Alembic Pharms |
10/12/2016 |
Enablex |
Darifenacin Hydrobromide |
Apil |
Jubilant Generics |
10/12/2016 |
Namenda XR |
Memantine Hydrochloride |
Forest Labs |
Amneal |
10/12/2016 |
Evista |
Raloxifene Hydrochloride |
Eli Lilly |
Sciegen Pharms |
10/14/2016 |
Prevacid |
Lansoprazole |
Takeda |
Ajanta Pharma |
10/14/2016 |
Avalide |
Irbesartan / Hydrochlorothiazide |
Sanofi Aventis US |
Hisun Pharm Hangzhou |
10/17/2016 |
Precedex |
Dexmedetomidine Hydrochloride |
Hospira |
Actavis |
10/17/2016 |
Perphenazine |
Perphenazine |
Sandoz |
Watson Labs |
10/21/2016 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Ascent Pharms |
10/21/2016 |
Concerta |
Methylphenidate Hydrochloride |
Janssen |
Mylan |
10/21/2016 |
Actonel |
Risedronate Sodium |
Apil |
Aurobindo Pharma |
10/21/2016 |
Sarafem |
Fluoxetine Hydrochloride |
Apil |
Torrent |
10/21/2016 |
Ortho-Novum 7/7/7-28 |
norethindrone / ethinyl estradiol |
Janssen |
Aurobindo Pharma |
10/21/2016 |
Modicon 28 |
Norethindrone / ethinyl estradiol |
Janssen |
Aurobindo Pharma |
10/21/2016 |
Ortho-Novum 1/35-28 |
norethindrone / ethinyl estradiol |
Janssen |
Aurobindo Pharma |
10/21/2016 |
Betapace |
Sotalol Hydrochloride |
Covis Pharma |
Beximco Pharms USA |
10/21/2016 |
Dextrose 5% in Plastic Container |
Dextrose 5% in Plastic Container |
B Braun / Baxter Healthcare / Hospira |
Fresenius Kabi USA |
10/21/2016 |
Synalar |
Fluocinolone Acetonide |
Medimetriks Pharms |
Actavis |
10/24/2016 |
Nystatin / Triamcinolone Acetonide |
Nystatin / Triamcinolone Acetonide |
Taro |
Glenmark |
10/26/2016 |
Benicar |
Olmesartan Medoxomil |
Daiichi Sankyo |
Mylan |
10/26/2016 |
Benicar HCT |
Olmesartan Medoxomil / Hydrochlorothiazide |
Daiichi Sankyo |
Mylan |
10/26/2016 |
Azor |
Amlodipine / Olmesartan Medoxomil |
Daiichi Sankyo |
Teva |
10/26/2016 |
Tribenzor |
Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide |
Daiichi Sankyo |
Torrent |
10/26/2016 |
Tribenzor |
Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide |
Daiichi Sankyo |
Par |
10/26/2016 |
Azor |
Amlodipine / Olmesartan Medoxomil |
Daiichi Sankyo |
MacLeods Pharms |
10/26/2016 |
Nystatin and Triamcinolone Acetonide |
Nystatin and Triamcinolone Acetonide |
Taro |
Dr Reddys |
10/27/2016 |
Robaxin |
Methocarbamol |
West-Ward Pharms |
Monterey Pharms |
10/27/2016 |
Acetazolamide |
Acetazolamide |
Taro |
Heritage Pharma |
10/27/2016 |
Ortho Cyclen-28 |
Norgestimate / Ethinyl Estradiol |
Janssen |
Lupin |
10/27/2016 |
Ipratropium Bromide |
Ipratropium Bromide |
Ritedose |
Aurobindo Pharma |
10/28/2016 |
Angiomax |
Bivalirudin |
The Medicines Co |
Fresenius Kabi USA |
10/28/2016 |
Ziagen |
Abacavir Sulfate |
VIIV Healthcare |
Strides Pharma |
10/28/2016 |
Cellcept |
Mycophenolate Mofetil Hydrochloride |
Roche Palo |
Par |
10/28/2016 |
Norpramin |
Desipramine Hydrochloride |
US Pharm |
Corepharma |
10/28/2016 |
MS Contin |
Morphine Sulfate |
Purdue Pharma |
Mayne Pharma |
10/28/2016 |
Butalbital / Acetaminophen / Caffeine |
Butalbital / Acetaminophen / Caffeine |
Nexgen Pharma |
Nuvo Pharm |
10/28/2016 |
Azor |
Amlodipine / Olmesartan Medoxomil |
Daiichi Sankyo |
Ajanta Pharma |
10/28/2016 |
Singulair |
Montelukast Sodium |
Merck |
Cipla |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Torrent Pharms |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Accord Healthcare |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Jubilant Generics |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Changzhou Pharm |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Hetero Labs |
10/31/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Biocon |
11/1/2016 |
Ketorolac Tromethamine |
Ketorolac Tromethamine |
Hospira |
Gland Pharma |
11/3/2016 |
Tribenzor |
Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide |
Daiichi Sankyo |
Teva |
11/3/2016 |
Ibuprofen |
Ibuprofen |
Actavis |
Hi-Tech Pharmacal |
11/4/2016 |
Duragesic-25 |
Fentanyl-25 |
Janssen |
3M Drug Delivery |
11/4/2016 |
Ortho Tri-Cyclen Lo |
norgestimate / ethinyl estradiol |
Janssen |
Aurobindo Pharma |
11/7/2016 |
Zegerid (OTC) |
Omeprazole / Sodium Bicarbonate |
Bayer Healthcare |
Aurolife Pharma |
11/7/2016 |
Topicort |
Desoximetasone |
Taro |
Actavis |
11/7/2016 |
Methylphenidate Hydrochloride |
Methylphenidate Hydrochloride |
Novel Labs |
Tedor Pharma |
11/8/2016 |
Optivar |
Azelastine Hydrochloride |
Meda Pharms |
Akorn |
11/9/2016 |
Phentermine Hydrochloride |
Phentermine Hydrochloride |
Sandoz |
Aurolife Pharma |
11/9/2016 |
Tylenol (OTC) |
Acetaminophen |
Johnson and Johnson Consumer |
Aurobindo Pharma |
11/9/2016 |
Solu-Medrol |
Methylprednisolone Sodium Succinate |
Pharmacia and Upjohn |
Amneal |
11/10/2016 |
Aricept ODT |
Donepezil Hydrochloride |
Eisai |
Unichem Labs |
11/10/2016 |
Aygestin |
Norethindrone Acetate |
Duramed Res |
Jai Pharma |
11/10/2016 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
Silarx Pharms |
11/14/2016 |
Hydrocodone Bitartrate / Acetaminophen |
Hydrocodone Bitartrate / Acetaminophen |
Mikart |
Novel Labs |
11/14/2016 |
Morphine Sulfate |
Morphine Sulfate |
Roxane |
Pharm Assoc |
11/14/2016 |
Afirmelle |
Levonorgestrel / Ethinyl Estradiol |
Mayne Pharma |
Aurobindo Pharma |
11/15/2016 |
Butalbital / Acetaminophen |
Butalbital / Acetaminophen |
Nexgen Pharma |
Mikart |
11/15/2016 |
Doryx |
Doxycycline Hyclate |
Mayne Pharma |
Prinston |
11/16/2016 |
Flagyl |
Metronidazole |
GD Searle |
Zydus |
11/17/2016 |
Enablex |
Darifenacin Hydrobromide |
Apil |
Torrent |
11/17/2016 |
Twynsta |
Telmisartan / Amlodipine |
Boehringer Ingelheim |
Alembic Pharms |
11/17/2016 |
Pravachol |
Pravastatin Sodium |
Bristol Myers Squibb |
Accord Healthcare |
11/18/2016 |
Intermezzo |
Zolpidem Tartrate |
Purdue Pharma |
Dr Reddys Labs |
11/18/2016 |
Adipex-P |
Phentermine Hydrochloride |
Teva |
Polygen Pharms |
11/18/2016 |
Methylin |
Methylphenidate Hydrochloride |
Mallinckrodt |
Abhai |
11/21/2016 |
Epivir |
Lamivudine |
VIIV Healthcare |
Aurobindo Pharma |
11/21/2016 |
Epivir |
Lamivudine |
VIIV Healthcare |
Aurobindo Pharma |
11/21/2016 |
Epivir |
Lamivudine |
VIIV Healthcare |
Appco Pharma |
11/22/2016 |
Detrol LA |
Tolterodine Tartrate |
Pharmacia and Upjohn |
Teva |
11/22/2016 |
Skelaxin |
Metaxalone |
King Pharms |
Lannett |
11/22/2016 |
Namenda XR |
Memantine Hydrochloride |
Forest Labs |
Apotex |
11/22/2016 |
Yasmin |
Drospirenone / Ethinyl Estradiol |
Bayer Healthcare |
Accord Healthcare |
11/23/2016 |
Ibuprofen |
Ibuprofen |
Dr Reddys |
Aiping Pharm |
11/23/2016 |
Temodar |
Temozolomide |
Merck Sharp Dohme |
Chemi Spa |
11/23/2016 |
Baraclude |
Entecavir |
Bristol Myers Squibb |
Par |
11/23/2016 |
Entocort EC |
Budesonide |
Perrigo |
Alvogen Malta |
11/23/2016 |
Crestor |
Rosuvastatin Calcium |
IPR |
Cadila Pharms |
11/23/2016 |
Oxycodone Hydrochloride |
Oxycodone Hydrochloride |
Vistapharm |
Wes Pharma |
11/25/2016 |
Azor |
Amlodipine / Olmesartan Medoxomil |
Daiichi Sankyo |
Torrent |
11/25/2016 |
Arthrotec |
Diclofenac Sodium / Misoprostol |
GD Searle |
Amneal |
11/25/2016 |
Toprol-XL |
Metoprolol Succinate |
AstraZeneca |
Actavis |
11/28/2016 |
Nuvigil |
Armodafinil |
Cephalon |
Lupin |
11/28/2016 |
Nuvigil |
Armodafinil |
Cephalon |
Natco Pharma |
11/28/2016 |
Zometa |
Zoledronic Acid |
Novartis |
Accord Healthcare |
11/28/2016 |
Fanapt |
Iloperidone |
Vanda Pharms |
Inventia Healthcare |
11/28/2016 |
Zinecard |
Dexrazoxane Hydrochloride |
Pharmacia and Upjohn |
Gland Pharma |
11/29/2016 |
Actonel |
Risedronate Sodium |
Apil |
MacLeods Pharms |
11/29/2016 |
Clozaril |
Clozapine |
Heritage Life |
Aurobindo Pharma |
11/29/2016 |
Cyproheptadine Hydrochloride |
Cyproheptadine Hydrochloride |
Ivax Sub Teva Pharms |
Appco Pharma |
11/29/2016 |
Hydrocodone Bitartrate / Acetaminophen |
Hydrocodone Bitartrate / Acetaminophen |
Mikart |
Amneal |
11/29/2016 |
Clobex |
Clobetasol Propionate |
Galderma Labs |
Teligent Pharma |
11/30/2016 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Par |
11/30/2016 |
Topicort |
Desoximetasone |
Taro |
Groupe Parima |
11/30/2016 |
Hycamtin |
Topotecan Hydrochloride |
Novartis |
Ingenius Pharms |
12/1/2016 |
Zomig-ZMT |
Zolmitriptan |
AstraZeneca |
Alembic Pharms |
12/1/2016 |
Norco |
Hydrocodone Bitartrate / Acetaminophen |
Apil |
Novel Labs |
12/1/2016 |
Dapsone |
Dapsone |
Jacobus |
Par |
12/1/2016 |
Topicort |
Desoximetasone |
Taro |
Lupin |
12/5/2016 |
Atacand |
Candesartan Cilexetil |
Astrazeneca |
MacLeods Pharms |
12/6/2016 |
Cytovene |
Ganciclovir |
Roche Palo |
Par |
12/6/2016 |
Baraclude |
Entecavir |
Bristol Myers Squibb |
Cipla |
12/6/2016 |
Zegerid |
Omeprazole / Sodium Bicarbonate |
Santarus |
Sciegen Pharms |
12/6/2016 |
Amantadine Hydrochloride |
Amantadine Hydrochloride |
Sandoz |
Watson |
12/7/2016 |
Elestat |
Epinastine Hydrochloride |
Allergan |
Alcon |
12/7/2016 |
Abilify |
Aripiprazole |
Otsuka |
Accord Healthcare |
12/7/2016 |
Glucophage XR |
Metformin Hydrochloride |
Bristol Myers Squibb |
MacLeods Pharms |
12/7/2016 |
Kenalog |
Triamcinolone Acetonide |
Ranbaxy Labs |
Akorn |
12/8/2016 |
Integrilin |
Eptifibatide |
Schering |
Amneal |
12/8/2016 |
Nitropress |
Sodium Nitroprusside |
Hospira |
Namigen |
12/12/2016 |
Xeloda |
Capecitabine |
Hoffmann La Roche |
Shilpa Medicare |
12/12/2016 |
Topicort |
Desoximetasone |
Taro |
Lupin |
12/13/2016 |
Sporanox |
Itraconazole |
Janssen |
Par |
12/13/2016 |
Sporanox |
Itraconazole |
Janssen |
Alembic Pharms |
12/13/2016 |
Nor-QD |
Norethindrone |
Apil |
Accord Healthcare |
12/13/2016 |
Glucophage XR |
Metformin Hydrochloride |
Bristol Myers Squibb |
Beximco Pharms |
12/13/2016 |
Percocet |
Oxycodone / Acetaminophen |
Vintage Pharms |
Cerovene |
12/15/2016 |
Nicorette (OTC) |
Nicotine Polacrilex |
GlaxoSmithKline |
Perrigo |
12/15/2016 |
Nicorette (OTC) |
Nicotine Polacrilex |
GlaxoSmithKline |
Perrigo |
12/15/2016 |
Amantadine Hydrochloride |
Amantadine Hydrochloride |
USL Pharma |
Watson |
12/15/2016 |
Tricor |
Fenofibrate |
Abbvie |
Cipla |
12/15/2016 |
Micardis HCT |
Telmisartan / Hydrochlorothiazide |
Boehringer Ingelheim |
Aurobindo Pharma |
12/16/2016 |
Elixophyllin |
Theophylline |
Nostrum Labs |
Pharm Assoc |
12/19/2016 |
Alkeran |
Melphalan Hydrochloride |
Apotex Inc |
Actavis |
12/20/2016 |
Prednisolone Sodium Phosphate |
Prednisolone Sodium Phosphate |
Pharm Assoc |
Edenbridge Pharms |
12/20/2016 |
Xyzal |
Levocetirizine Dihydrochloride |
UCB Inc |
Nostrum Labs |
12/20/2016 |
Livalo |
Pitavastatin Calcium |
Kowa Co |
Aurobindo Pharma |
12/20/2016 |
Zyvox |
Linezolid |
Pharmacia and Upjohn |
Nang Kuang Pharm |
12/20/2016 |
Nystatin / Triamcinolone Acetonide |
Nystatin / Triamcinolone Acetonide |
Taro |
Perrigo |
12/21/2016 |
Zovirax |
Acyclovir |
Valeant Bermuda |
Taro |
12/22/2016 |
Cordran |
Flurandrenolide |
Aqua Pharms |
Teligent Pharma |
12/22/2016 |
Lotronex |
Alosetron Hyrdochloride |
Sebela Ireland |
Amneal |
12/23/2016 |
Topicort |
Desoximetasone |
Taro |
G and W Labs |
12/23/2016 |
Tretinoin |
Tretinoin |
Barr Labs |
Glenmark Generics |
12/27/2016 |
Geodon |
Ziprasidone Hydrochloride |
Pfizer |
Aurobindo Pharma |
12/27/2016 |
Indomethacin |
Indomethacin |
Sandoz |
Aurobindo Pharma |
12/27/2016 |
Cyproheptadine Hydrochloride |
Cyproheptadine Hydrochloride |
Lyne |
Patrin Pharma |
12/27/2016 |
Norethindrone Acetate / Ethinyl Estradiol |
Norethindrone Acetate / Ethinyl Estradiol |
Barr Labs |
Jai Pharma |
12/27/2016 |
Kaletra |
Lopinavir / Ritonavir |
Abbvie |
Silarx Pharms |
12/29/2016 |
Glucotrol XL |
Glipizide |
Pfizer |
Unique Pharm Labs |
12/29/2016 |
Treanda |
Bendamustine Hydrochloride |
Cephalon |
Breckenridge |
12/29/2016 |
Nystatin / Triamcinolone Acetonide |
Nystatin / Triamcinolone Acetonide |
Taro |
RiconPharma |
12/29/2016 |
Cyproheptadine Hydrochloride |
Cyproheptadine Hydrochloride |
Ivax Sub Teva Pharms |
Apex Pharms |
12/30/2016 |
Evoxac |
Cevimeline Hydrochloride |
Daiichi Sankyo |
Novel Labs |
12/30/2016 |
Augmentin '875' |
Amoxicillin / Clavulanate Potassium |
Dr Reddys Labs |
Micro Labs |
12/30/2016 |
Augmentin '250' / Augmentin '500' |
Amoxicillin / Clavulanate Potassium |
Dr Reddys Labs |
Micro Labs |
12/30/2016 |
Cleocin T |
Clindamycin Phosphate |
Pharmacia and Upjohn |
Teligent Pharma |
12/30/2016 |
Xopenex |
Levalbuterol Hydrochloride |
Oak Pharms |
Aurobindo Pharma |
12/30/2016 |
Cordran |
Flurandrenolide |
Aqua Pharms |
Teligent Pharma |
12/30/2016 |
Nystatin / Triamcinolone Acetonide |
Nystatin / Triamcinolone Acetonide |
Taro |
Teligent Pharma |