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 |