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ANDA Approvals
Fall 2016
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 7/5/2016 | Hydrocodone Bitartrate / Acetaminophen | Hydrocodone Bitartrate / Acetaminophen | Mikart | Par |
| 7/5/2016 | Hiprex | Methenamine Hippurate | US Pharm Holdings | Aurobindo |
| 7/5/2016 | Tobramycin Sulfate | Tobramycin Sulfate | Fresenius Kabi USA | Claris |
| 7/6/2016 | Granisetron Hydrochloride | Granisetron Hydrochloride | Teva / Fresenius Kabi USA | Aurobindo |
| 7/6/2016 | Starlix | Nateglinide | Novartis | Zydus |
| 7/6/2016 | Ortho Tri-Cyclen | Ethinyl Estradiol / Norgestimate | Janssen | Aurobindo Pharma |
| 7/7/2016 | Ortho Cyclen-28 | Ethinyl Estradiol / Norgestimate | Janssen | Aurobindo Pharma |
| 7/7/2016 | Triamcinolone Acetonide | Triamcinolone Acetonide | Wockhardt | Teligent Pharma |
| 7/7/2016 | Exalgo | Hydromorphone Hydrochloride | Mallinckrodt | Osmotica |
| 7/11/2016 | Zymaxid | Gatifloxacin | Allergan | Alcon |
| 7/11/2016 | Glucophage | Metformin Hydrochloride | Bristol-Myers Squibb | CSPC Ouyi Pharm |
| 7/11/2016 | Norvasc | Amlodipine Besylate | Pfizer | Polygen Pharms |
| 7/12/2016 | Tricor | Fenofibrate | Abbvie | Hetero Labs |
| 7/13/2016 | Temodar | Temozolomide | Merck Sharp Dohme | Amerigen |
| 7/13/2016 | Naropin | Ropivacaine Hydrochloride | Fresenius Kabi USA | Aurobindo Pharma |
| 7/14/2016 | Xeloda | Capecitabine | Hoffmann LA Roche | Roxane |
| 7/14/2016 | Pyridoxine Hydrochloride | Pyridoxine Hydrochloride | Fresenius Kabi USA | Mylan |
| 7/15/2016 | Zegerid (OTC) | Omeprazole / Sodium Bicarbonate (OTC) | Bayer Healthcare | Perrigo |
| 7/15/2016 | Zegerid (OTC) | Omeprazole / Sodium Bicarbonate (OTC) | Bayer Healthcare | Par |
| 7/15/2016 | Zegerid (OTC) | Omeprazole / Sodium Bicarbonate (OTC) | Bayer Healthcare | Actavis |
| 7/15/2016 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Dr Reddys Labs |
| 7/15/2016 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Ajanta Pharma |
| 7/15/2016 | Nilandron | Nilutamide | Concordia Pharms | ANI Pharms |
| 7/18/2016 | Valcyte | Valganciclovir Hydrochloride | Hoffmann LA Roche | Actavis |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Apotex |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Mylan |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Teva |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Par |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Sun Pharma |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Aurobindo Pharma |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Sandoz |
| 7/19/2016 | Crestor | Rosuvastatin Calcium | IPR | Glenmark |
| 7/21/2016 | Avalide | Irbesartan / Hydrochlorothiazide | Sanofi Aventis | Mylan |
| 7/22/2016 | Triamcinolone Acetonide | Triamcinolone Acetonide | Perrigo | Glenmark |
| 7/25/2016 | Marcaine | Bupivacaine Hydrochloride | Hospira | Claris |
| 7/26/2016 | Prevacid | Lansoprazole | Takeda | Anchen Pharms |
| 7/27/2016 | Phoslo Gelcaps | Calcium Acetate | Fresenius | Lotus Pharm |
| 7/27/2016 | Klor-Con M20 | Potassium Chloride | Upsher Smith Labs | Glenmark |
| 7/27/2016 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Ajanta Pharma |
| 7/28/2016 | Zyloprim | Allopurinol | Sebela Ireland | Indoco Remedies |
| 7/28/2016 | Metadate CD | Methylphenidate Hydrocholoride | UCB | Corepharma |
| 7/29/2016 | Pristiq | Desvenlafaxine Succinate | Wyeth | Actavis |
| 8/1/2016 | Edluar | Zolpidem Tartrate | Meda | Par |
| 8/1/2016 | Glumetza | Metformin Hydrochloride | Santarus | Sun Pharma |
| 8/1/2016 | Glumetza | Metformin Hydrochloride | Santarus | Actavis |
| 8/3/2016 | Tamiflu | Oseltamivir Phosphate | Roche | Natco Pharma |
| 8/3/2016 | Cymbalta | Duloxetine Hydrochloride | Lilly | Hetero Labs |
| 8/4/2016 | Gleevec | Imatinib Mesylate | Novartis | Teva |
| 8/4/2016 | Zyvox | Linezolid | Pharmacia and Upjohn | Aurobindo Pharma |
| 8/5/2016 | Gleevec | Imatinib Mesylate | Novartis | Apotex |
| 8/5/2016 |
Buprenorphine Hydrochloride
/ Naloxone Hydrochloride
|
Buprenorphine Hydrochloride
/
Naloxone Hydrochloride
|
Actavis | Sun Pharm |
| 8/5/2016 | Razadyne ER | Galantamine Hydrobromide | Janssen | Aurobindo Pharma |
| 8/5/2016 | Triamcinolone Acetonide | Triamcinolone Acetonide | Fougera Pharms | Glenmark |
| 8/8/2016 | Edluar | Zolpidem Tartrate | Meda Pharms | Mylan |
| 8/8/2016 | Vfend | Voriconazole | PF Prism | Prinston |
| 8/9/2016 | Klor-Con | Potassium Chloride | Upsher-Smith Labs | Novel Labs |
| 8/10/2016 | Nexium IV | Esomeprazole Sodium | AstraZeneca | Aurobindo Pharma |
| 8/11/2016 | Triamcinolone Acetonide | Triamcinolone Acetonide | Taro | Versapharm |
| 8/12/2016 | Topicort | Desoximetasone | Taro | Groupe Parima |
| 8/15/2016 | Potassium Chloride | Potassium Chloride | Actavis | Novel Labs |
| 8/15/2016 | Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride Allergy (OTC) | Bionpharma | Apotex |
| 8/17/2016 | Zemplar | Paricalcitol | Abbvie | Dr Reddys Labs |
| 8/17/2016 | Zyban | Bupropion Hydrochloride | GlaxoSmithKline | Sciegen Pharms |
| 8/18/2016 | Reclast | Zoledronic Acid | Novartis | Gland Pharma |
| 8/19/2016 | Sarafem | Fluoxetine Hydrochloride | Mylan / Apil | Par |
| 8/19/2016 | Felodipine | Felodipine | Mylan | Jubilant Generics |
| 8/19/2016 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Aurolife Pharma |
| 8/19/2016 | Diclegis |
Doxylamine Succinate /
Pyridoxine Hydrochloride
|
Duchesnay | Actavis |
| 8/19/2016 | Wellbutrin | Bupropion Hydrochloride | GlaxoSmithKline | Heritage Pharma |
| 8/19/2016 | Klor-Con | Potassium Chloride | Upsher-Smith Labs | Sigmapharm Labs |
| 8/22/2016 | Micardis | Telmisartan | Boehringer Ingelheim | Jubilent Generics |
| 8/22/2016 | Alkeran | Melphalan Hydrochloride | Apotex | Par |
| 8/22/2016 | Zyvox | Linezolid | Pharmacia and Upjohn | Novel Labs |
| 8/23/2016 | Trospium Chloride | Trospium Chloride | Glenmark Generics | Invagen Pharms |
| 8/23/2016 | Zantac 300 | Ranitidine Hydrochloride | Glaxo | Strides Pharma |
| 8/24/2016 | Augmentin '875' |
Amoxicillin /
Clavulanate Potassium
|
Dr Reddys Labs | Hikma Pharms |
| 8/24/2016 | Miralax (OTC) | Polyethylene Glycol 3350 (OTC) | Bayer Healthcare | Strides Pharma |
| 8/24/2016 | Edecrin | Ethacrynate Sodium | Aton | Mylan |
| 8/24/2016 | Paclitaxel | Pacitaxel | Hospira | Gland Pharma |
| 8/25/2016 | Adalat CC | Nifedipine | Alvogen | Novast Labs |
| 8/25/2016 | Duac |
Clindamycin Phosphate /
Benzoyl Peroxide
|
Stiefel | Tolmar |
| 8/25/2016 | MS Contin | Morphine Sulfate | Purdue Pharma | Sun Pharm |
| 8/26/2016 | Nitrostat | Nitroglycerin | Pfizer Pharms | Dr Reddys Labs |
| 8/30/2016 | Trospium Chloride | Trospium Chloride | Glenmark Generics | Heritage Pharms |
| 8/30/2016 | Zyprexa | Olanzapine | Lilly | Ajanta Pharma |
| 8/30/2016 | Cordran | Flurandrenolide | Aqua Pharms | Perrigo |
| 9/1/2016 | Enablex | Darifenacin Hydrobromide | Apil | Cipla |
| 9/2/2016 | Levonorgestrel | Levonorgestrel | Perrigo | Lotus Pharm |
| 9/2/2016 | Levonorgestrel (OTC) | Levonorgestrel (OTC) | Perrigo | Lotus Pharm |
| 9/2/2016 | Levonorgestrel | Levonorgestrel | Perrigo | Jai Pharma |
| 9/2/2016 | Levonorgestrel (OTC) | Levonorgestrel (OTC) | Perrigo | Jai Pharma |
| 9/2/2016 | Pennsaid | Diclofenac Sodium | Nuvo Res | Amneal |
| 9/7/2016 | Trilipix | Fenofibric Acid | Abbvie | Impax Labs |
| 9/7/2016 | Advil Liqui-Gels (OTC) | Ibuprofen (OTC) | Pfizer | Sofgen Pharms |
| 9/7/2016 | Vfend | Voriconazole | PF Prism CV | Versapharm |
| 9/8/2016 | Naftin | Naftifine Hydrochloride | Merz Pharms | Taro |
| 9/8/2016 | Feldene | Piroxicam | Pfizer | Flamingo Pharms |
| 9/9/2016 | Hectorol | Doxercalciferol | Genzyme | Rising Pharms |
| 9/9/2016 | Kariva | Volnea | Barr | Sandoz |
| 9/9/2016 | Dermotic | Fluocinolone Acetonide | Hill Dermac | Versapharm |
| 9/9/2016 | Vimpat | Lacosamide | UCB | Amneal |
| 9/9/2016 | Lidocaine | Lidocaine | Fougera | Glenmark |
| 9/12/2016 | Abilify | Aripiprazole | Otsuka | Ajanta Pharma |
| 9/13/2016 | Solaraze | Diclofenac Sodium | Fougera Pharms | Glenmark |
| 9/15/2016 | Accupril | Quinapril Hydrochloride | Pfizer | Prinston |
| 9/15/2016 | Ritalin | Methylphenidate Hydrocholoride | Novartis | Cnty Line Pharms |
| 9/15/2016 | Lunesta | Eszopiclone | Sunovion Pharms | Aurobindo Pharma |
| 9/16/2016 | Keppra | Levetiracetam | UCB | Mylan |
| 9/16/2016 | Exforge |
Amlodipine Besylate / Valsartan |
Novartis | Invagen Pharms |
| 9/19/2016 | Aldactone | Spironolactone | GD Searle | Accord Healthcare |
| 9/19/2016 | Buprenorphine Hydrochloride / Naloxone Hydrochloride |
Buprenorphine Hydrochloride /
Naloxone Hydrochloride
|
Actavis | Kremers Urban Pharms |
| 9/19/2016 | Enablex | Darifenacin Hydrobromide | Apil | Aurobindo Pharma |
| 9/20/2016 | Diovan | Valsartan | Novartis | MacLeods Pharms |
| 9/20/2016 | Bromfed-DM |
Brompheniramine Maleate/
Pseudoephedrine Hydrochloride/
Dextromethorphan Hydrobromide
|
Wockhardt | Acella Pharms |
| 9/21/2016 | Argatroban | Argatroban | Pfizer | Hospira |
| 9/21/2016 | Yasmin | Drospirenone and Ethinyl Estradiol | Bayer Healthcare | Apotex |
| 9/22/2016 | Butalbital, Aspirin and Caffeine | Butalbital, Aspirin and Caffeine | Hikma | Pharmaceutics |
| 9/23/2016 | Claritin | Loratadine (OTC) | Bayer Healthcare | Marksans Pharma |
| 9/23/2016 | Levora 0.15/30-28 | Ayuna | Mayne Pharma | Aurobindo Pharma |
| 9/23/2016 | Nor-QD | Incassia | Apil | Aurobindo Pharma |
| 9/26/2016 | Ziagen | Abacavir Sulfate | VIIV Healthcare | Hetero Labs |
| 9/26/2016 | Sporanox | Itraconazole | Janssen | Amneal |
| 9/26/2016 | Zometa | Zoledronic Acid | Novartis | Aurobindo Pharma |
| 9/28/2016 | Namenda XR | Memantine Hydrochloride | Forest Labs | Sun Pharma |
| 9/28/2016 | Namenda XR | Memantine Hydrochloride | Forest Labs | Lupin |
| 9/28/2016 | Namenda XR | Memantine Hydrochloride | Forest Labs | Mylan |
| 9/28/2016 | Synalar | Fluocinolone Acetonide | Medimetriks Pharms | G and W Labs |
| 9/29/2016 | Epzicom | Abacavir Sulfate and Lamivudine | VIIV Healthcare | Teva |
| 9/29/2016 | Lithobid | Lithium Carbonate | ANI Pharms | Heritage Pharma |
| 9/29/2016 | Ability | Aripiprazole | Otsuka | Sciegen Pharms |
| 9/29/2016 | Vidaza | Azacitidine | Celgene | Shilpa Medicare |
| 9/30/2016 | Diamox | Acetazolamide | Teva | Novast Labs |
| 9/30/2016 | Betimol | Timolol | Oak Pharms | Akorn |
| 9/30/2016 | Amantadine Hydrochloride | Amantadine Hydrochloride | Sandoz | Newgen Pharms |
|
Amlodipine Besylate / Valsartan |
GENERICally Speaking Fall 2016
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