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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Cerebyx Injection Pfizer Fosphenytoin Sodium Injection Amneal indicated for the control of generalized tonic-clonic epilepsy and the prevention and treatment of seizures occurring during neurosurgery 10/6/2016
Lamictal ODT GSK Lamotrigine Orally Disintegrating Tablets Dr. Reddy's Labs treatment of certain types of seizures in epileptic patients 10/10/2016
Merrem AztraZeneca Meropenem for Injection Amneal treatment for intra-abdominal infections and bacterial meningitis 10/12/2016
Beyaz Bayer Rajani Teva oral contraceptive 10/12/2016
Abilify Otsuka Aripiprazole Tablets Dr. Reddy's Labs used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression) 10/13/2016
Vagifem Novo Nordisk Yuvafem Amneal used after menopause to treat menopausal changes in and around the vagina 10/18/2016
Benicar Daiichi Sankyo Olmesartan Medoxomil Tablets Mylan indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure 10/26/2016
Benicar HCT Daiichi Sankyo Olmesartan Medoxomil / Hydrochlorothiazide Tablets Mylan indicated for treatment of hypertension to lower blood pressure, and are not indicated for the initial therapy of hypertension 10/26/2016
Entocort EC Perrigo Budesonide Extended Release Capsules Mayne Pharma used as treatment for patients with mild to moderate Crohn's disease 10/27/2016
Benicar Daiichi Sankyo Olmesartan Medoxomil Tablets Sun Pharm indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure 10/27/2016
Benicar HCT Daiichi Sankyo Olmesartan Medoxomil / Hydrochlorothiazide Tablets Sun Pharm indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure 10/27/2016
Azor Daiichi Sankyo Amlodipine Besylate / Olmesartan Medoxomil Tablets Sun Pharm used to treat high blood pressure (hypertension) 10/27/2016
Tribenzor Daiichi Sankyo Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil Tablets Sun Pharm used to treat high blood pressure (hypertension) 10/27/2016
Crestor AstraZeneca Rosuvastatin Tablets Camber Pharms used to treat high cholesterol and triglyceride levels 10/31/2016
Seroquel XR AstraZeneca Quetiapine Fumarate Extended Release (ER) Tablets Endo add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and schizophrenia 11/1/2016
Azor Daiichi Sankyo Amlodipine Besylate / Olmesartan Medoxomil Tablets Ajanta used to treat high blood pressure (hypertension) 11/2/2016
Avodart GlaxoSmithKline Dutasteride Capsules Camber Pharms used to treat enlarged prostrate 11/3/2016
Levaquin Ortho-McNeil-Janssen Levofloxacin Tablets Camber Pharms used to treat a variety of bacterial infections 11/3/2016
MS Contin Purdue Pharma Morphine Sulfate Extended-Release Tablets Mayne Pharma an opioid analgesic for moderate to severe pain management 11/3/2016
Angiomax The Medicines Company Bivalirudin for Injection Fresenius Kabi USA used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty 11/7/2016
Tribenzor Daiichi Sankyo Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil Tablets Teva indicated for treatment of hypertension, to lower blood pressure 11/7/2016
Azor Daiichi Sankyo Amlodipine Besylate / Olmesartan Medoxomil Tablets Teva indicated for treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure 11/7/2016
Methergine Edison Therapeutics Methylergonovine Maleate Injection Breckenridge / Ergoject used for the prevention and control of postpartum hemorrhage 11/9/2016
Evista Eli Lilly Raloxifene Hydrochloride Tablets Dr. Reddy's Labs prevention and treatment of osteoporosis 11/11/2016
Ditropan XL Janssen Oxybutynin Chloride Extended-Release Tablets Aceto used in the treatment of overactive bladder 11/14/2016
Activella Amneal Amabelz Tablets Lupin indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis 11/15/2016
Abilify Otsuka Aripiprazole Tablets Ajanta used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression) 11/16/2016
Benzamycin Gel Valeant Erythromycin / Benzoyl Peroxide Topical Gel Aceto used in treatment of acne vulgaris 11/17/2016
Temodar Merck Sharp & Dohme Temozolomide Capsules Mayne Pharma indicated for the treatment of adult patients with newly diagnosed cancerous brain tumors known as glioblastoma multiform concomitantly with radiotherapy and then as maintenance treatment 11/21/2016
Nuvigil Cephalon Armodafinil Tablets Breckenridge / Natco indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD) 11/28/2016
Nystatin and Triamcinolone Acetonide Cream Taro Pharms Nystatin / Triamcinolone Acetonide Cream Dr. Reddy's Labs used to treat fungal skin infections 12/5/2016
Tygacil Pfizer Tigecycline for Injection Fresenius Kabi USA tetracycline class antibacterial indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections; complicated intra-abdominal infections; and community acquired bacterial pneumonia 12/5/2016
CellCept Hoffman-LaRoche Mycophenolate Mofetil Hydrochloride for Injection Endo indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney, heart, or liver transplants 12/6/2016
Vancocin ViroPharma Vancomycin HCI Capsules ANI Pharms indicated for treatment of C. difficile-associated diarrhea 12/10/2016
Tamiflu Hoffman-LaRoche Oseltamivir Phosphate Capsules Alvogen used to treat the flu (influenza) 12/12/2016
Zetia Merck Ezetimibe Tablets Endo / Glenmark indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia 12/12/2016
Zetia Merck Ezetimibe Tablets Endo / Glenmark indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol 12/12/2016
EpiPen Auto-Injector Mylan Epinephrine Injection Mylan emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens 12/16/2016
Vfend PF Prism Voriconazole Tablets / Voriconazole Oral Suspension Lupin indicated for use in patients 12 years of age and older in the treatment of fungal infections 12/19/2016
Lithobid Noven Pharms Lithium Carbonate Extended Release Tablets ANI Pharms used in the treatment of manic episodes of Bipolar Disorder, Manic (DSM-IV) 12/21/2016
Kadian Allergan Morphine Sulfate Extended Release Tablets Impax Labs indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate 12/22/2016
Zovia 1/50E-28 Tablets Watson Ethynodiol Diacetate / Ethinyl Estradiol Tablets Mylan indicated for use by women to prevent pregnancy 12/28/2016
Cerebyx Pfizer Fosphenytoin Sodium Injection Mylan treatment of certain types of severe seizures 12/29/2016
Concerta Janssen Methylphenidate Hydrochloride Extended-Release Tablets Mylan treatment of Attention Deficit Hyperactivity Disorder (ADHD) 12/29/2016

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