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ANDA Approvals
Winter 2017

Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
10/3/2017 | DDAVP | Desmopressin Acetate | Ferring | Zydus Pharms |
10/3/2017 | Copaxone | Glatiramer Acetate | Teva | Mylan |
10/3/2017 | Toviaz | Fesoterodine Fumarate | Pfizer | Zydus Pharms |
10/3/2017 | Copaxone | Glatiramer Acetate | Teva | Mylan |
10/3/2017 | Micardis | Telmisartan | Boehringer Ingelheim | Micro Labs |
10/4/2017 | Avodart | Dutasteride | GlaxoSmithKline | Zydus Pharms |
10/4/2017 | Vigamox | Moxifloxacin HCl | Novartis | Aurobindo |
10/5/2017 | Effexor XR | Venlafaxine HCl | Wyeth | MacLeods |
10/5/2017 | Corgard | Nadolol | US Worldmeds | Lupin |
10/6/2017 | Actos | Pioglitazone HCl | Takeda | Puracap Pharm |
10/6/2017 | Viramune XR | Nevirapine | Boehringer Ingelheim | MacLeods |
10/6/2017 | Acticlate | Doxycyline Hyclate | Aqua Pharms | Amneal |
10/10/2017 | Nuedexta | Dextromethorphan Hydrobromide / Quinidine Sulfate | Avanir Pharms | Actavis |
10/10/2017 | Cleocin | Clindamycin Phosphate | Pharmacia and Upjohn | Mylan |
10/10/2017 | Cleocin | Clindamycin Phosphate | Pharmacia and Upjohn | Mylan |
10/10/2017 | Baraclude | Entecavir | Bristol Myers Squibb | Prinston |
10/11/2017 | Pristiq | Desvenlafaxine Succinate | Wyeth | Zydus Pharms |
10/11/2017 | Mepron | Atovaquone | GlaxoSmithKline | Apotex |
10/12/2017 | Emend | Aprepitant | Merck | Glenmark |
10/12/2017 | Zyloprim | Allopurinol | Casper Pharma | Zydus Pharms |
10/13/2017 | Gabitril | Tiagabine HCl | Cephalon | Wilshire Pharms |
10/13/2017 | Avodart | Dutasteride | GlaxoSmithKline | Haupt Pharma |
10/13/2017 | Tobi | Tobramycin | Novartis | Mylan |
10/16/2017 | Nitrostat | Nitroglycerin | Pfizer | Actavis |
10/16/2017 | Effient | Prasugrel | Eli Lilly and Co | Liberty Pharma |
10/16/2017 | Effient | Prasugrel | Eli Lilly and Co | Aurobindo |
10/16/2017 | Effient | Prasugrel | Eli Lilly and Co | Panacea Biotec |
10/16/2017 | Zemplar | Paricalcitol | AbbVie | Akorn |
10/16/2017 | Gastrocrom | Cromolyn Sodium | Mylan | Ailex Pharms |
10/16/2017 | Nexium 24Hr (OTC) | Esomeprazole Magnesium (OTC) | AstraZeneca | Aurobindo |
10/16/2017 | Aczone | Dapsone | Allergan | Taro |
10/17/2017 | Ancobon | Flucytosine | Valeant | West-Ward |
10/18/2017 | Bumex | Bumetanide | Validus Pharms | Amneal |
10/20/2017 | Lodosyn | Carbidopa | Aton | Novel Labs |
10/20/2017 | Prometrium | Progesterone | Virtus Pharms | Sandoz |
10/20/2017 | Nexium | Esomeprazole Magnesium | AstraZeneca | Alkem Labs |
10/23/2017 | Renvela | Sevelamer Carbonate | Genzyme | Impax Labs |
10/23/2017 | Kapvay | Clonidine HCl | Concordia Pharms | Lupin |
10/23/2017 | Klor-Con | Potassium Chloride | Pharma Res Software | Upsher-Smith Labs |
10/25/2017 | Coreg CR | Carvedilol Phosphate | SmithKline Beecham | Sun Pharm Industries |
10/25/2017 | Nexterone | Amiodarone HCl | Baxter Healthcare | Aurobindo |
10/25/2017 | Levetiracetam in Sodium Chloride | Levetiracetam in Sodium Chloride | HQ Specialty Pharma | Gland Pharma |
10/26/2017 | Neurontin | Gabapentin | Pfizer | Jiangsu Hengrui Med |
10/26/2017 | Renvela | Sevelamer Carbonate | Genzyme | Invagen Pharms |
10/26/2017 | Neurontin | Gabapentin | Pfizer | CSPC Ouyi Pharm |
10/27/2017 | Reclast | Zoledronic Acid | Novartis | Mylan |
10/27/2017 | Methadone HCl | Methadone HCl | Mylan | Akorn |
10/27/2017 | Clobex | Clobetasol Propionate | Galderma Labs | Hi-Tech Pharmacal |
10/27/2017 | Zometa | Zoledronic Acid | Novartis | Cipla |
10/27/2017 | Dilaudid | Hydromorphone HCl | Rhodes | Ascent Pharms |
10/30/2017 | Azilect | Rasagiline Mesylate | Teva | Alkem Labs |
10/30/2017 | Xylocaine | Lidocaine HCl | Fresenius Kabi USA | Aurobindo |
10/30/2017 | Allegra-D | Fexofenadine HCl / Pseudoephedrine HCl (OTC) | Sanofi Aventis | Aurobindo |
10/31/2017 | Acetadote | Acetylcysteine | Cumberland Pharms | Sagent Pharms |
10/31/2017 | Glucophage | Metformin HCl | Bristol Myers Squibb | MacLeods |
10/31/2017 | Dexedrine | Dextroamphetamine Sulfate | Impax Labs | Vintage Pharms |
10/31/2017 | Boniva | Ibandronate Sodium | Hoffmann La Roche | MacLeods |
10/31/2017 | Tamiflu | Oseltamivir Phosphate | Roche | Alvogen Pine Brook |
11/2/2017 | Zemplar | Paricalcitol | AbbVie | Mylan |
11/2/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Micro Labs |
11/3/2017 | Wellbutrin XL | Bupropion HCl | Valeant | TWi |
11/6/2017 | Hyzaar | Losartan Potassium / Hydrochlorothiazide | Merck Sharp Dohme | Prinston |
11/6/2017 | Clolar | Clofarabine | Genzyme | Dr Reddys Labs |
11/6/2017 | Integrilin | Eptifibatide | Schering | Accord Healthcare |
11/6/2017 | Clolar | Clofarabine | Genzyme | Amneal |
11/6/2017 | Clolar | Clofarabine | Genzyme | Mylan |
11/6/2017 | Micardis HCT | Telmisartan / Hydrochlorothiazide | Boehringer Ingelheim | Prinston |
11/8/2017 | Motrin IB (OTC) | Ibuprofen (OTC) | Johnson and Johnson | Aurobindo |
11/9/2017 | Vigamox | Moxifloxacin HCl | Novartis | Akorn |
11/9/2017 | Cosmegen | Dactinomycin | Recordati Rare | Mylan |
11/9/2017 | Diprolene | Betamethasone Dipropionate | Merck Sharp Dohme | Teligent Pharma |
11/9/2017 | Children's Allegra | Fexofenadine HCl | Sanofi Aventis | Taro Pharm |
11/9/2017 | Children's Allegra | Fexofenadine HCl | Sanofi Aventis | Taro Pharm |
11/9/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley / Vistapharm | Ascent Pharms |
11/13/2017 | Cellcept | Mycophenolate Mofetil | Roche Palo | Zhejiang Hisun Pharm |
11/13/2017 | Zovirax | Acyclovir | Valeant | G and W Labs |
11/13/2017 | Zocor | Simvastatin | Merck Sharp Dohme | Hisun Pharm Hangzhou |
11/13/2017 | Zantac 150 (OTC) | Ranitidine HCl (OTC) | Sanofi | Aurobindo |
11/13/2017 | Zantac 75 (OTC) | Ranitidine HCl (OTC) | Sanofi | Aurobindo |
11/14/2017 | Eloxatin | Oxaliplatin | Sanofi Aventis / Teva | Mylan |
11/16/2017 | Solodyn | Minocycline HCl | Medicis | Zydus Pharms |
11/16/2017 | Cellcept | Mycophenolate Mofetil | Roche Palo | Zhejiang Hisun Pharm |
11/16/2017 | Lotrimin Ultra (OTC) | Butenafine HCl (OTC) | Bayer Healthcare | Taro |
11/16/2017 | Intuniv | Guanfacine HCl | Shire | Sun Pharm Inds |
11/16/2017 | Pulmicort | Budesonide | AstraZeneca | Cipla |
11/16/2017 | Dacogen | Decitabine | Otsuka | Cipla |
11/16/2017 | Fluoxetine HCl | Fluoxetine HCl | Alvogen | Par |
11/17/2017 | Cytovene | Ganciclovir | Roche Palo | Mylan |
11/17/2017 | Loestrin 24 Fe | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Glenmark |
11/17/2017 | Abstral | Fentanyl Citrate | Sentynl Theraps | Actavis |
11/17/2017 | Edecrin | Ethacrynate Sodium | Aton | Zydus Pharms |
11/20/2017 | Choline C-11 | Choline C-11 | MCPRF | UCSF Rodiopharm |
11/20/2017 | Busulfex | Myleran | Otsuka | Aspen Global |
11/20/2017 | Focalin | Dexmethylphenidate HCl | Novartis | Rhodes |
11/20/2017 | Kapvay | Clonidine HCl | Concordia Pharms | Ajanta |
11/20/2017 | Fluoxetine HCl | Fluoxetine HCl | Alvogen | Inventia Healthcare |
11/20/2017 | Kapvay | Clonidine HCl | Concordia Pharms | Xiamen LP Pharm |
11/20/2017 | Kapvay | Clonidine HCl | Concordia Pharms | Amneal |
11/21/2017 | Ziagen | Abacavir Sulfate | VIIV Healthcare | Cipla |
11/21/2017 | Prezista | Darunavir Ethanolate | Janssen | Teva |
11/21/2017 | Loestrin Fe 1/20 | Hailey Fe 1/20 | Apil | Glenmark |
11/21/2017 | Vytorin | Ezetimibe and Simvastatin | Merck Sharp Dohme | Amneal |
11/21/2017 | Locoid | Hydrocortisone Butyrate | Precision Dermat | Teligent Pharma |
11/21/2017 | Avodart | Dutasteride | GlaxoSmithKline | Humanwell Puracap |
11/22/2017 | Angiomax | Bivalirudin | The Medicines Co | Accord Healthcare |
11/22/2017 | Crestor | Rosuvastatin Calcium | IPR | MSN Labs |
11/24/2017 | Robaxin | Methocarbamol | West-Ward | Navinta |
11/24/2017 | Topotecan HCl | Topotecan Hydrochloride | Hospira | Mylan |
11/24/2017 | Trokendi XR | Topiramate | Supernus Pharms | Zydus Pharms |
11/24/2017 | Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container | Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container | Hospira / B Braun & Baxter Healthcare & Hospira & ICU Medical | Fresenius Kabi USA |
11/27/2017 | Capastat Sulfate | Capreomycin Sulfate | Akorn | Mylan |
11/27/2017 | Atacand HCT | Candesartan Cilexetil and Hydrochlorothiazide | AstraZeneca | Zydus Pharms |
11/27/2017 | Xeloda | Capecitabine | Hoffmann La Roche | Alkem Labs |
11/27/2017 | Biltricide | Praziquantel | Bayer Healthcare | Par |
11/28/2017 | Depo-Provera | Medroxyprogesterone Acetate | Pharmacia and Upjohn | Amphastar Pharms |
11/28/2017 | Depo-Provera | Medroxyprogesterone Acetate | Pharmacia and Upjohn | Amphastar Pharms |
11/28/2017 | Precedex | Dexmedetomidine Hydrochloride | Hospira | Teva |
11/28/2017 | Renvela | Sevelamer Carbonate | Genzyme | Amneal |
11/29/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | MacLeods |
11/29/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Accord Healthcare |
11/29/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Aurobindo |
11/29/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Novast Labs |
11/29/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Sciegen Pharms |
11/30/2017 | Remodulin | Treprostinil | United Therap | Sandoz |
11/30/2017 | Zantac 150 / Zantac 300 | Ranitidine Hydrochloride | Glaxo Grp | Acic Pharms |
11/30/2017 | Heparin Sodium | Heparin Sodium | Fresenius Kabi USA & West-Ward | Mylan |
11/30/2017 | Heparin Sodium | Heparin Sodium | Fresenius Kabi USA | Mylan |
11/30/2017 | Prograf | Tacrolimus | Astellas | Belcher Pharms |
12/1/2017 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Anchen Pharms |
12/1/2017 | Megace ES | Megestrol Acetate | Endo | Breckenridge |
12/1/2017 | Advil Cold and Sinus (OTC) | Ibuprofen and Pseudoephedrine Hydrochloride (OTC) | Pfizer | Aurobindo |
12/4/2017 | Abilify | Aripiprazole | Otsuka | Prinston |
12/5/2017 | Pataday | Olopatadine Hydrochloride | Novartis | Apotex |
12/5/2017 | Pataday | Olopatadine Hydrochloride | Novartis | Akorn |
12/5/2017 | Pataday | Olopatadine Hydrochloride | Novartis | Cipla |
12/6/2017 | Zyvox | Linezolid | Pharmacia and Upjohn | Mylan |
12/6/2017 | Gemcitabine HCl | Gemcitabine HCl | Hospira | Mylan |
12/6/2017 | Magnesium Sulfate in Plastic Container | Magnesium Sulfate in Plastic Container | Hospira | HQ Specialty Pharma |
12/6/2017 | Diclegis | Doxylamine Succinate and Pyridoxine Hydrochloride | Duchesnay | Par |
12/6/2017 | Clozaril | Clozapine | Heritage Life | Zydus Pharms |
12/6/2017 | Clolar | Clofarabine | Genzyme | MSN Labs |
12/8/2017 | Melphalan HCl | Melphalan HCl | Dr Reddys Labs | Dr Reddys Labs |
12/8/2017 | Locoid Lipocream | Hydrocortisone Butyrate | Precision Dermat | Actavis |
12/8/2017 | Busulfex | Busulfan | Otsuka | Actavis |
12/8/2017 | Cytovene | Ganciclovir Sodium | Roche Palo | Pharmascience |
12/8/2017 | Enablex | Darifenacin Hydrobromide | Apil | Alembic |
12/8/2017 | Gabitril | Tiagabine Hydrochloride | Cephalon | Amneal |
12/8/2017 | Reclast | Zoledronic Acid | Novartis | Aurobindo |
12/11/2017 | Kenalog-40 | Triamcinolone Acetonide | Apothecon | Amneal |
12/12/2017 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Zydus Pharms |
12/12/2017 | Macrodantin | Nitrofurantoin | Alvogen Malta | Zydus Pharms |
12/12/2017 | Safyral | Tydemy | Bayer Healthcare | Lupin |
12/12/2017 | Detrol LA | Tolterodine Tartrate | Pharmacia and Upjohn | Hetero Labs |
12/12/2017 | Valcyte | Valganciclovir Hydrochloride | Hoffmann La Roche | Dr Reddys Labs |
12/12/2017 | Flagyl | Metronidazole | GD Searle | Cadila Pharms |
12/14/2017 | Cafcit | Caffeine Citrate | West-Ward | Micro Labs |
12/14/2017 | Inapsine | Droperidol | Akorn | Eurohealth Intl |
12/15/2017 | Sustiva | Efavirenz | Bristol Myers Squibb | Aurobindo |
12/15/2017 | Duac | Clindamycin Phosphate / Benzoyl Peroxide | Stiefel | Taro |
12/15/2017 | Astepro | Azelastine HCl | Mylan | Amneal |
12/18/2017 | Mesnex | Mesna | Baxter Healthcare | Gland Pharma |
12/18/2017 | Xenazine | Tetrabenazine | Valeant | Bionpharma |
12/18/2017 | Busulfex | Busulfan | Otsuka | Amneal |
12/19/2017 | Exforge HCT | Amlodipine Besylate / Valsartan / Hydrochlorothiazide | Novartis | Aurobindo |
12/19/2017 | Procardia XL | Nifedipine | Pfizer | Zydus Pharms |
12/21/2017 | Advil Liqui-Gels | Ibuprofen (OTC) | Pfizer | Ascent Pharms |
12/21/2017 | Zetia | Ezetimibe | Merck Sharp Dohme | Alkem Labs |
12/22/2017 | Melphalan HCl | Melphalan HCl | Dr Reddys Labs | Fresenius Kabi USA |
12/22/2017 | Ativan | Lorazepam | Valeant Intl | Aurolife Pharma |
12/22/2017 | Avage / Tazorac | Tazarotene | Allergan | G and W Labs |
12/22/2017 | Vytorin | Ezetimibe / Simvastatin | Merck Sharp Dohme | Alkem Labs |
12/22/2017 | Zyrtec | Cetirizine HCl | Johnson and Johnson | Granules India |
12/22/2017 | Yaz | Drospirenone / Ethinyl Estradiol | Bayer Healthcare | Cyndea Pharma |
12/22/2017 | Methotrexate Sodium | Methotrexate Sodium | Dava Pharms | Amneal |
12/26/2017 | Fortamet | Metformin HCl | Andrx Labs | Nostrum Labs |
12/26/2017 | Norpramin | Desipramine HCl | US Pharm Holdings | Ingenus Pharms |
12/26/2017 | Arixtra | Fondaparinux Sodium | Mylan | Aurobindo |
12/26/2017 | Triamcinolone Acetonide | Triamcinolone Acetonide | Mylan | Alkem Labs |
12/26/2017 | Synalar | Fluocinolone Acetonide | Medimetriks Pharms | Glasshouse Pharms |
12/26/2017 | Minastrin 24 Fe | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Glenmark |
12/27/2017 | Seasonique | Jaimiess | Teva | Labs Leon Farma |
12/27/2017 | Anafranil | Clomipramine HCl | Mallinckrodt | Zydus Pharms |
12/29/2017 | Valtrex | Valacyclovir HCl | GlaxoSmithKline | Zydus Pharms |
12/29/2017 | Feldene / Piroxicam | Piroxicam | Pfizer / Micro Labs | Micro Labs |
12/29/2017 | Zometa | Zoledronic Acid | Novartis | BPI Labs |
12/29/2017 | Mucinex D (OTC) | Guaifenesin, Pseudoephedrine HCl (OTC) | Reckitt Benckiser | Dr Reddys Labs |
GENERICally Speaking Winter 2017
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