ANDA Approvals

Summer 2016

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/4/2016 Polymyxin B Sulfate Polymyxin B Sulfate Eurohealth Intl Aurobindo Pharma
4/8/2016 Entocort EC Budesonide Perrigo Actavis
4/8/2016 Evista Raloxifene Hydrochloride Eli Lilly Amneal
4/11/2016 Fludeoxyglucose F18 Fludeoxyglucose F18 Queen Hamamatsu Pet Kreitchman Pet Ctr
4/11/2016 Gemcitabine Hydrochloride Gemcitabine Hydrochloride Hospira Actavis
4/12/2016 Kadian Morphine Sulfate Allergan Impax Labs
4/12/2016 Norco Hydrocodone Bitartrate / Acetaminophen Watson Labs / Actavis Rhodes Pharms
4/12/2016 Aricept Donepezil Hydrochloride Eisai Indicus Pharma
4/12/2016 Merrem Meropenem AstraZeneca Amneal
4/12/2016 Temodar Temozolomide Merck Sharp Dohme IDT Australia
4/12/2016 Roxicodone Oxycodone Hydrochloride Mallinckrodt Ken Lifescience
4/13/2016 Vfend Voriconazole PF Prism CV Amneal
4/13/2016 Cordran SP Flurandrenolide Aqua Pharms Teligent Pharma
4/14/2016 Zyfrel Hydrocodone Bitartrate / Acetaminophen Mikart Cypress Pharm
4/14/2016 Glyburide Glyburide Teva Pharmadax
4/14/2016 Polymyxin B Sulfate Polymyxin B Sulfate Eurohealth Intl Gland Pharma
4/15/2016 Lexiva Fosamprenavir Calcium VIIV Healthcare Mylan
4/15/2016 Surmontil Trimipramine Maleate Odyssey Pharms Crossmedika
4/19/2016 Latisse Bimatoprost Allergan Sandoz
4/19/2016 Indocin Indomethacin Sodium Recordati Rare Hospira
4/19/2016 Merrem Meropenem AstraZeneca Savior Lifetec
4/20/2016 Cytomel Liothyronine Sodium King Pharms Sun Pharm
4/21/2016 Aloxi Palonosetron Hydrochloride Helsinn Healthcare Dr. Reddys Labs
4/21/2016 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Actavis
4/21/2016 Nexium Esomeprazole Magnesium AstraZeneca Aurobindo Pharma
4/22/2016 Xalatan Latanoprost Pharmacia and Upjohn FDC
4/22/2016 Savella Milnacipran Hydrochloride Cypress Bioscience Amneal
4/22/2016 Micardis Telmisartan Boehringer Ingelheim Hetero Labs
4/25/2016 Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Lyne
4/25/2016 Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Lyne
4/25/2016 Dermotic  Fluocinolone Acetonide Hill Dermac Lyne
4/25/2016 Exforge Amlodipine Besylate / Valsartan Novartis Aurobindo Pharma
4/26/2016 Opana Oxymorphone Hydrochloride Endo Pharms Aurolife Pharma
4/26/2016 Ortho Tri-Cyclen Norgestimate / Ethinyl Estradiol Janssen Pharms Lupin
4/26/2016 Pepcid AC (OTC) Famotidine (OTC) Johnson and Johnson Aurobindo Pharma
4/26/2016 Cortef Hydrocortisone Pharmacia and Upjohn Pharmaceutics Intl
4/27/2016 Temodar Temozolomide Merck Sharp Dohme Lotus Pharm
4/28/2016 Hydralazine Hydrochloride Hydralazine Hydrochloride Akorn Mylan
4/28/2016 Vimpat Lacosamide UCB Amneal
4/28/2016 Vimpat Lacosamide UCB Actavis
4/28/2016 Vimpat Lacosamide UCB MSN Labs PVT
4/28/2016 Vimpat Lacosamide UCB Alembic Pharms
4/28/2016 Vimpat Lacosamide UCB Aurobindo Pharma
4/28/2016 Vimpat Lacosamide UCB Mylan
4/28/2016 Vimpat Lacosamide UCB Sun Pharma
4/28/2016 Solaraze Diclofenac Sodium Fougera Pharms Taro
4/29/2916 Crestor Rosuvastatin Calcium IPR Watson Labs
4/29/2016 Glucophage XR Metformin Hydrochloride Bristol Myers Squibb Marksans Pharma
4/29/2016 Roxicodone Oxycodone Hydrochloride Mallinckrodt Coastal Pharms 
4/29/2016 Rythmol SR Propafenone Hydrochloride GlaxoSmithKline Mylan
4/29/2016 Vidaza Azacitidine Celgene Mylan
5/2/2016 Cambia Diclofenac Potassium Depomed Par
5/3/2016 Lioresal Baclofen Saol Theraps Res Sintetica
5/3/2016 Camptosar Irinotecan Hydrochloride Pfizer Qilu Pharm Co
5/3/2016 Furadantin Nitrofurantoin Shionogi Actavis
5/5/2016 Tricor Fenofibrate Abbvie Aurobindo Pharma
5/5/2016 Norpramin Desipramine Hydrochloride US Pharm Holdings Indicus Pharma
5/6/2016 Natazia Estradiol Valerate / Dienogest Bayer Healthcare Watson Labs
5/6/2016 Dapsone Dapsone Jacobus Nostrum Labs
5/6/2016 Buphenyl Sodium Phenylbutyrate Horizon Pharma Par
5/10/2016 Dapsone Dapsone Jacobus North Creek Pharms
5/10/2016 Nicorette (OTC) Nicotine Polacrilex (OTC) GlaxoSmithKline Actavis
5/10/2016 Glyburide Glyburide Teva Zydus Pharms USA
5/10/2016 Topicort Desoximetasone Taro Novel Labs
5/11/2016 Rythmol Propafenone Hydrochloride GlaxoSmithKline Orion Corp Orion
5/11/2016 Oxaliplatin Oxaliplatin Sun Pharma Qilu Pharm Co
5/11/2016 Zovirax Acyclovir Valeant Bermuda Fougera Pharms
5/11/2016 Zomig Zolmitriptan IPR Aurbindo Pharma
5/12/2016 Ortho Tri-Cyclen Lo Norgestimate / Ethinyl Estradiol Janssen Pharms Haupt Pharma
5/13/2016 Triamcinolone Acetonide Triamcinolone Acetonide Perrigo Teligent Pharma
5/13/2016 Dilaudid Hydromorphone Hydrochloride Purdue Pharm Aurolife Pharma
5/13/2016 Marcaine  Bupivacaine Hydrochloride Hospira Aurobindo Pharma
5/16/2016 Banzel Rufinamide Eisai Roxane
5/16/2016 Banzel Rufinamide Eisai Glenmark Pharms
5/16/2016 Banzel Rufinamide Eisai Mylan
5/16/2016 Flagyl Metronidazole GD Searle Flamingo Pharms
5/17/2016 Seroquel Quetiapine Fumarate AstraZeneca Macleods Pharms
5/18/2016
Bacteriostatic Sodium 
Chloride 0.9% in Plastic 
Container / Sodium 
Chloride 0.9% Plastic Container
Bacteriostatic Sodium 
Chloride 0.9% in 
Plastic Container / 
Sodium Chloride 0.9% 
Plastic Container
Hospira / Baxter 
Healthcare / 
Fresenius Kabi 
USA / Taro 
Pharms Ireland
Jubilant Hollistrstr
5/19/2016 Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Taro
5/19/2016 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Kreitchman Pet Ctr
5/19/2016 Lipitor Atorvastatin Calcium Pfizer Sciegen Pharms
5/19/2016 Treanda Bendamustine Hydrochloride Cephalon Accord Healthcare
5/19/2016 Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Taro Pharm Inds
5/20/2016 Zomig Zolmitriptan IPR Ajanta Pharma
5/20/2016 Treanda Bendamustine Hydrochloride Cephalon Hospira
5/23/2016 Restoril Temazepam Mallinckrodt Amneal Pharms
5/24/2016 Vfend Voriconazole PF Prism CV Ajanta Pharma
5/24/2016 Minastrin 24 FE
norethindrone 
acetate / ethinyl estradiol / 
ferrous fumarate
Apil Lupin
5/24/2016 Vfend Voriconazole PF Prism CV Zydus Pharms USA
5/24/2016 Vfend Voriconazole PF Prism CV Appco Pharma
5/24/2016 Vfend Voriconazole PF Prism CV Novel Labs
5/26/2016 Cleocin Clindamycin Palmitate Hydrochloride Pharmacia and Upjohn Mylan
5/27/2016 Robaxin Methocarbamol Eurohealth Intl Aurbindo Pharma
5/31/2016 Lo Loestrin FE
Norethindrone 
Acetate / Ethinyl 
Estradiol / Ethinyl 
Estradiol / Ferrous 
Fumarate
Apil Jai Pharma
5/31/2016 Vfend Voriconazole PF Prism CV Novel Labs
5/31/2016 Amantadine Hydrochloride Amantadine Hydrochloride Sandoz Zydus Pharms USA
6/1/2016 Prevacid 24 Hr (OTC) Lansoprazole (OTC) Novartis Mylan
6/2/2016 Vicoprofen
Hydrocodone 
Bitartrate / Ibuprofen
Abbvie Aurolife Pharma
6/2/2016 Hydrocodone Bitartrate / Acetaminophen
Hydrocodone 
Bitartrate / Acetaminophen
Mikart Actavis
6/2/2016 Keppra Levetiracetam UCB Jubilant Life
6/3/2016 Leribane
Norethindrone 
Acetate / Ethinyl 
Estradiol
Barr Labs Novast Labs
6/3/2016 Femara Letrozole Novartis Hikma Pharms
6/3/2016 Cordarone
Amiodarone 
Hydrochloride
Wyeth Aurobindo Pharma
6/6/2016 Keppra XR Levetiracetam UCB Lotus Pharm Co
6/6/2016 Tikosyn Dofetilide Pfizer Tiger Pharms
6/7/2016 Eloxatin Oxaliplatin Sanofi Aventis US / Teva Qilu Pharm Co
6/8/2016 Merrem Meropenem AstraZeneca Gland Pharma
6/9/2016 Zantac Ranitidine Hydrochloride IGI Labs Mylan
6/9/2016 Merrem Meropenem AstraZeneca Par
6/9/2016 Emend Fosaprepitant Dimeglumine Merck Fresenius Kabi USA
6/9/2016 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Akorn
6/10/2016 Sprycel Dasatinib Bristol Myers Squibb Apotex
6/10/2016 Neomycin Sulfate Neomycin Sulfate Teva Lannett Holdings
6/10/2016 Paxil CR
Paroxetine 
Hydrochloride
Apotex Kremers Urban Pharms
6/10/2016 Heparin Sodium Heparin Sodium Eurohealth Intl / Fresenius Kabi USA Fresenius Kabi USA
6/13/2016 Minocycline Hydrochloride
Minocycline 
Hydrochloride
Sandoz Aurobindo Pharma
6/13/2016 Ofirmev Acetaminophen Mallinckrodt Paddock
6/14/2016 Precedex
Dexmedetomidine 
Hydrochloride
Hospira Sandoz
6/14/2016 Avodart Dutasteride GlaxoSmithKline Mylan
6/14/2016 Avapro Irbesartan Sanofi Aventis Hisun Pharm Hangzhou
6/15/2016 Norco
Hydrocodone 
Bitartrate / 
Acetaminophen
Watson Labs / Actavis Larken Labs
6/15/2016 Buphenyl
Sodium 
Phenylbutyrate
Horizon Pharma Par
6/15/2016 Cubicin Daptomycin Cubist Crane Pharms
6/16/2016 Fusilev Levoleucovorin Calcium Spectrum Pharms Eurohlth Intl
6/17/2016 Lopid Gemfibrozil Pfizer Pharms Cadila Pharms
6/17/2016 Abilify Aripiprazole Otsuka Amneal
6/17/2016 Lamictal ODT Lamotrigine GlaxoSmithKline Sciegen Pharms
6/20/2016 Robinul / Robinul Forte Glycopyrrolate Casper Pharma Natco Pharma
6/20/2016 Activella Amabelz Amneal Lupin
6/20/2016 Revatio Sildenafil Citrate Pfizer Rubicon Res
6/21/2016
Advil Liqui-Gels / 
Advil Migraine Liqui-
Gels (OTC)
Ibuprofen (OTC) Pfizer Puracap Pharm
6/23/2016 MS Contin Morphine Sulfate Purdue Pharma Corepharma
6/23/2016 Aricept Donepezil Hydrochloride Eisai Unichem Labs
6/23/2016 Fenoglide Fenofibrate Santarus Mylan
6/23/2016 Primaquine Primaquine Phosphate Sanofi Aventis Ingenius Pharms
6/23/2016 Nystatin / Triamcinolone Acetonide
Nystatin / 
Triamcinolone Acetonide
Taro Glenmark Pharms
6/23/2016 Differin Adapalene Galderma Labs Taro
6/24/2016 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Macleods Pharms
6/24/2016 Diazepam Diazepam Roxane Lannett Holdings
6/27/2016 Vibramcycin Doxycycline Hyclate Pfizer Amneal
6/29/2016 Naloxone Hydrochloride Naloxone Hydrochloride Hospira Mylan
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