ANDA Approvals

Winter 2016

GENERICally Speaking
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

Amlodipine Besylate / Valsartan

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