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ANDA Approvals
Winter 2016
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 |
GENERICally Speaking Winter 2016
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