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ANDA Approvals
Spring 2016
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
1/4/2016 | Diovan | Valsartan | Novartis | Ivax |
1/5/2016 | Gemzar | Gemcitabine Hydrochloride | Eli Lilly | Gland Pharma |
1/6/2016 | Naftin | Naftifine Hydrochloride | Merz Pharms | Taro |
1/7/2016 | Nystatin | Nystatin | Wockhardt | Pharm Assoc |
1/7/2016 | Dapsone | Dapsone | Jacobus | Fera Pharms |
1/8/2016 | Aygestin | Norethindrone Acetate | Duramed Res | Aurobindo |
1/8/2016 | Lodosyn | Carbidopa | Aton | Alvogen Malta |
1/8/2016 | Unasyn | Ampicillin / Sulbactam | Pfizer | Sagent Pharms |
1/11/2016 | Unasyn | Ampicillin / Sulbactam | Pfizer | Sagent Pharms |
1/11/2016 | Diovan | Valsartan | Novartis | Amneal |
1/11/2016 | Felbatol | Felbamate | Meda Pharms | Mylan |
1/11/2016 | Xyzal | Levocetirizine Dihydrochloride | UCB | MacLeods Pharms |
1/12/2016 | Singulair | Montelukast Sodium | Merck | Anbison Lab |
1/13/2016 | Prevacid 24 Hr (OTC) | Lansoprazole (OTC) | Novartis | Natco Pharma |
1/13/2016 | Zemplar | Paricalcitol | Abbvie | Amneal |
1/13/2016 | Pindolol | Pindolol | Mylan | Nostrum Labs |
1/14/2016 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Aurobindo |
1/14/2016 | Avelox | Moxifloxacin Hydrochloride | Bayer | Crossmedika |
1/14/2016 | Zemplar | Paricalcitol | Abbvie | Aurobindo |
1/15/2016 | Avalide | Irbesartan / Hydrochlorothiazide | Sanofi Aventis | Int'l Specialty Chemicals |
1/19/2016 | Potassium Chloride | Potassium Chloride | Actavis | Glenmark |
1/19/2016 | Rifadin | Rifampin | Sanofi Aventis | Watson |
1/20/2016 | Silenor | Doxepin Hydrochloride | Pernix Theraps | Mylan |
1/21/2016 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA / Hospira | Gland Pharma |
1/21/2016 | Klor-Con M20 | Potassium Chloride | Upsher Smith | Novel Labs |
1/22/2016 | Vfend | Voriconazole | PF Prism | Aurobindo |
1/26/2016 | Exjade | Deferasirox | Novartis | Actavis |
1/26/2016 | Protonix | Pantoprazole Sodium | Wyeth | Amneal |
1/27/2016 | Lescol XL | Fluvastatin Sodium | Novartis | Teva |
1/27/2016 | Ortho Cyclen-28 | Norgestimate / Ethinyl Estradiol | Janssen | Jai Pharma |
1/27/2016 | Zyprexa | Olanzapine | Eli Lilly | Qilu Pharm |
1/27/2016 | Dexedrine | Dextroamphetamine Sulfate | Amedra Pharms | Mylan |
1/28/2016 | Uroxatral | Alfuzosin Hydrochloride | Concordia Pharms | Unichem Labs |
1/29/2016 | Minocycline Hydrochloride | Minocycline Hydrochloride | Par | Sun Pharm |
1/29/2016 | Buprenorphine Hydrochloride | Burprenorphine Hydrocloride | Roxane | Sun Pharm |
1/29/2016 | Peridex | Periogard | 3M | Colgate-Palmolive |
2/1/2016 | Maxipime | Cefepime Hydrochloride | Hospira | Qilu Pharm |
2/1/2016 | Keppra | Levetiracetam | UCB | Aurobindo |
2/1/2016 | Lidocaine | Lidocaine | Fougera | Teligent Pharma |
2/1/2016 | Celebrex | Celecoxib | GD Searle | Aurobindo |
2/2/2016 | Isosulfan Blue | Isosulfan Blue | Mylan | Aurobindo |
2/3/2016 | Xenazine | Tetrabenazine | Valeant | Hetero Labs |
2/3/2016 | Ammonia N 13 | Ammonia N 13 | Feinstein | MA General Hosp |
2/4/2016 | Neurontin | Gabapentin | Pfizer | Sciegen Pharms |
2/5/2016 | Zyvox | Linezolid | Pharmacia and Upjohn | Gate Pharms |
2/5/2016 | Boniva | Ibandronate Sodium | Roche | Accord Healthcare |
2/5/2016 | Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate | Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate | Barr | Actavis |
2/8/2016 | Diovan HCT | Valsartan / Hydrochlorothiazide | Novartis | Prinston |
2/9/2016 | Precedex | Dexmedetomidine Hydrochloride | Hospira | Accord Healthcare |
2/9/2016 | Zovia 1/50E-28 | Ethynodiol Diacetate / Ethinyl Estradiol | Watson Labs | Jai Pharma |
2/9/2016 | Wellbutrin SR | Bupropion Hydrochloride | GlaxoSmithKline | Invagen Pharms |
2/10/2016 | Temodar | Temozolomide | Merck Sharp Dohme | Kremers Urban |
2/10/2016 | Levaquin in Dextrose 5% in Plastic Container | Levofloxacin in Dextrose 5% in Plastic Container | Janssen | Aurobindo |
2/16/2016 | Adderall XR 30 | Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate | Shire | Impax Labs |
2/16/2016 | Macrodantin | Nitrofurantoin | Alvogen Malta | Sun Pharm |
2/16/2016 | Solu-Medrol | Methylprednisolone Sodium Succinate | Pharmacia and Upjohn | Hikma Farmaceutica |
2/16/2016 | Pristiq | Desvenlafaxine Succinate | Wyeth | Roxane |
2/17/2016 | Sustiva | Efavirenz | Bristol Myers Squibb | Mylan |
2/17/2016 | Flouorouracil | Flouorouracil | Accord Healthcare / Fresenius Kabi USA/Teva | Sagent Pharms |
2/17/2016 | Lodosyn | Carbidopa | Aton | Edenbridge Pharms |
2/18/2016 | Maxalt | Rizatriptan Benzoate | Merck | Alkem Labs |
2/18/2016 | Neurontin | Gabapentin | Pfizer | Sciegen Pharms |
2/18/2016 | Monodox | Doxycycline | Aqua Pharms | Zydus |
2/18/2016 | Dantrium | Dantrolene Sodium | Par Sterile Products | Mylan |
2/19/2016 | Claforan | Cefotaxime Sodium | Sanofi Aventis / US Pharm Holdings | Hospira |
2/19/2016 | Aricept | Donepezil Hydrochloride | Eisai | Dexcel Pharma |
2/19/2016 | Imitrex | Sumatriptan | GlaxoSmithKline | Lannett |
2/23/2016 | Ortho Tri-Cyclen Lo | Norgestimate / Ethinyl Estradiol | Janssen | Glenmark |
2/23/2016 | Keppra XR | Levetiracetam | UCB | Intellipharmaceutics |
2/23/2016 | Zipsor | Diclofenac Potassium | Depomed | Bionpharma |
2/24/2016 | Zemplar | Paricalcitol | Abbvie | Lotus Pharm |
2/24/2016 | Ammonul | Sodium Phenylacetate / Sodium Benzoate | Medicis | Ailex Pharms |
2/25/2016 | Amidate | Etomidate | Hospira | Hikma Farmaceutica |
2/25/2016 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | North Creek Pharms |
2/25/2016 | Topicort | Desoximetasone | Taro | Teligent Pharma |
2/26/2016 | Nicorette (OTC) | Nicotine Polacrilex (OTC) | GlaxoSmithKline | Actavis |
2/29/2016 | Clarithromycin | Clarithromycin | Teva | Allied Pharma |
2/29/2016 | Metadate ER | Methylphenidate Hydrochloride | UCB | Tedor Pharma |
2/29/2016 | Acyclovir Sodium | Acyclovir Sodium | Fresenius Kabi USA | Hikma Pharms |
2/29/2016 | Glucovance | Glyburide / Metformin Hydrochloride | Bristol Myers Squibb | Zydus |
2/29/2016 | Ditropan XL | Oxybutynin Chloride | Janssen | Accord Healthcare |
2/29/2016 | Acetadote | Acetylcysteine | Cumberland Pharms | Aurobindo |
2/29/2016 | Flonase Allergy Relief (OTC) | Fluticasone Propionate (OTC) | GlaxoSmithKline | Apotex |
3/1/2016 | Wellbutrin SR | Bupropion Hydrochloride | GlaxoSmithKline | Sciegen Pharms |
3/2/2016 | Magnesium Sulfate in Dextrose 5% in Plastic Container | Magnesium Sulfate in Dextrose 5% in Plastic Containers | Hospira | HQ Specialty Pharma |
3/3/2016 | Rifadin | Rifampin | Sanofi Aventis | Hikma Pharms |
3/3/2016 | Axert | Almotriptan Malate | Janssen | Ajanta Pharma |
3/4/2016 | Potassium Chloride | Potassium Chloride | Actavis | Tris Pharma |
3/4/2016 | Epivir | Lamivudine | VIIV Healthcare | Mylan |
3/7/2016 | Oxistat | Oxiconazole Nitrate | Fougera Pharms | Taro |
3/7/2016 | Magnesium Sulfate in Dextrose 5% in Plastic Container | Magnesium Sulfate in Dextrose 5% in Plastic Container | Hospira | Fresenius Kabi USA |
3/8/2016 | Seroquel | Quetiapine Fumarate | AstraZeneca | Unichem Labs |
3/8/2016 | Pulmicort Respules | Budesonide | AstraZeneca | Teva |
3/8/2016 | Aggrenox | Aspirin / Dipyridamole | Boehringer Ingelheim | Amneal |
3/8/2016 | Children's Cetirizine Hydrochloride Allergy | Children's Cetirizine Hydrochloride Allergy | Sandoz | Novel Labs |
3/8/2016 | Zofran Preservative Free | Ondansetron Hydrochloride Preservative Free | Novartis | Accord Healthcare |
3/11/2016 | Boniva | Ibandronate Sodium | Hoffmann LA Roche | Aurobindo |
3/11/2016 | Frova | Frovatriptan Succinate | Endo | Glenmark |
3/11/2016 | Plan B One-Step | Levonorgestrel | Teva Branded | Novast Labs |
3/14/2016 | Neurontin | Gabapentin | Parke Davis | Tris Pharma |
3/15/2016 | Azilect | Rasagiline Mesylate | Teva Branded | Orchid Healthcare |
3/15/2016 | Zyprexa | Olanzapine | Eli Lilly | Invagen |
3/15/2016 | Zyvox | Linezolid | Pharmacia and Upjohn | Fresenius Kabi USA |
3/15/2016 | Magnesium Sulfate in Plastic Container | Magnesium Sulfate in Plastic Container | Hospira | Fresenius Kabi USA |
3/16/2016 | Zyprexa Zydis | Olanzapine | Eli Lilly | Invagen |
3/16/2016 | Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | Barr | Novel Labs |
3/16/2016 | Celebrex | Celecoxib | GD Searle | MacLeods |
3/17/2016 | Precedex | Dexmedetomidine Hydrochloride | Hospira | Aurobindo |
3/17/2016 | Avodart | Dutasteride | GlaxoSmithKline | Intergel Pharms |
3/17/2016 | Norpramin | Desipramine Hydrochloride | US Pharm Holdings | Amneal |
3/18/2016 | Valcyte | Valganciclovir Hydrochloride | Hoffmann LA Roche | Hetero Labs |
3/18/2016 | Aleve (OTC) | Naproxen Sodium (OTC) | Bayer | Aurobindo |
3/18/2016 | Voltaren | Diclofenac Sodium | GlaxoSmithKline | Amneal |
3/22/2016 | Nasonex | Mometasone Furoate | Merck Sharp Dohme | Apotex |
3/22/2016 | Xopenex | Levalbuterol Hydrochloride | Oak Pharms | Ritedose |
3/22/2016 | Ofirmev | Acetaminophen | Mallinckrodt | Sandoz |
3/22/2016 | Evista | Raloxifene Hydrochloride | Eli Lilly | Novel Labs |
3/23/2016 | Femcon Fe | Norethindrone / Ethinyl Estradiol / Ferrous Fumarate | Allergan | Lupin |
3/23/2016 | Temodar | Temozolomide | Merck Sharp Dohme | Lannett |
3/23/2016 | Vfend | Voriconazole | PF Prism CV | Alvogen |
3/24/2016 | Temodar | Temozolomide | Merck Sharp Dohme | Roxane |
3/24/2016 | Treanda | Bendamustine Hydrochloride | Cephalon | Glenmark |
3/24/2016 | Treanda | Bendamustine Hydrochloride | Cephalon | Innopharma |
3/24/2016 | Thyroshield (OTC) | Potassium Iodide (OTC) | Arco Pharms | Mission Pharmacal |
3/25/2016 | Cubicin | Daptomycin | Cubist | Teva |
3/25/2016 | Zovirax | Acyclovir | Delcor Asset | Zydus |
3/25/2016 | Exelon | Rivastigmine Tartrate | Novartis | Aurobindo |
3/25/2016 | Yasmin | Drospirenone / Ethinyl Estradiol | Bayer | Glenmark |
3/25/2016 | Plan B One-Step | Levonorgestrel | Teva Branded | Glenmark |
3/28/2016 | Potassium Chloride | Potassium Chloride | Actavis | Kremers Urban |
3/28/2016 | Carboplatin | Carboplatin | Pharmachemie / Teva | Sanja Pharms |
3/28/2016 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA / Hospira | Aurobindo |
3/28/2016 | Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | Barr | Nesher Pharms |
3/29/2016 | Diamox | Acetazolamide | Teva Branded | Nostrum Labs |
3/30/2016 | Neoprofen | Ibuprofen Lysine | Recordati Rare | Exela Pharma Science |
3/30/2016 | Rilutek | Riluzole | Covis Pharma | Alkem Labs |
3/30/2016 | Protonix IV | Pantoprazole Sodium | Wyeth Pharms Inc | Aurobindo |
3/31/2016 | Lexapro | Escitalopram Oxalate | Forest Labs | MacLeods Pharms |
3/31/2016 | Valcyte | Valganciclovir Hydrochloride | Hoffmann LA Roche | Aurobindo |
3/31/2016 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Lehigh Valley | Ani Pharms |
3/31/2016 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA/Hospira | Aurobindo |
GENERICally Speaking Spring 2016
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