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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Fenoglide Santarus Fenofibrate Tablets Mylan indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides, and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia 7/6/2016
Paxil CR Apotex Paroxetine Extended-Release Tablets Lannett used to treat depression 7/11/2016
Temodar Merck Temozolomide Capsules Mylan indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment 7/11/2016
Zegerid Santarus Omeprazole / Sodium Bicarbonate Capsules Ajanta short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE 7/18/2016
Nilandron Covis Pharmaceuticals Nilutamide Tablets ANI Pharmaceuticals indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2) 7/18/2016
Zegerid Santarus Omeprazole / Sodium Bicarbonate Capsules Dr. Reddy's Laboratories short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE 7/18/2016
Zegerid OTC Merck Omeprazole / Sodium Bicarbonate OTC Capsules Perrigo short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE 7/18/2016
Axert Janssen Almotriptan Malate Tablets Ajanta indicated for acute migraine pain treatment for adults and teens 7/19/2016
Crestor AstraZeneca Rosuvastatin Calcium Tablets Citron Pharma is an antihyperlipidemic to prevent cardiovascular disease 7/19/2016
Crestor IPR Pharmaceuticals Rosuvastatin Calcium Tablets Aurobindo Pharma is an antihyperlipidemic to prevent cardiovascular disease 7/20/2016
Xeloda Hoffmann-La Roche Capecitabine Tablets Hikma Pharmaceuticals / West-Ward Pharmaceuticals indicated for adjuvant treatment in patients with Dukes' C colon cancer, as monotherapy in metastatic colorectal cancer, and in combination with docetaxel or as montherapy in patients with metastatic breast cancer 7/20/2016
Ortho Tri-Cyclen Johnson & Johnson Norgestimate / Ethinyl Estradiol Tablets Lupin indicated for use by females of reproductive potential to prevent pregnancy 7/20/2016
Crestor AstraZeneca Rosuvastatin Calcium Tablets Mylan is an antihyperlipidemic to prevent cardiovascular disease 7/20/2016
Crestor IPR Pharmaceuticals Rosuvastatin Calcium Tablets Apotex is an antihyperlipidemic to prevent cardiovascular disease 7/22/2016
Propecia Merck Finasteride Tablets Mylan treatment of male pattern hair loss (androgenetic alopecia) for men only 8/1/2016
Dexedrine Amedra Pharmaceuticals Dextroamphetamine Sulfate Extended-Release Capsules Mylan indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment program with typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome 8/1/2016
Gleevec Novartis Oncology Imatinib Mesylate Tablets Teva indicated for newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) 8/5/2016
Fusilev Spectrum Pharmaceuticals Levoleucovorin for Injection Hikma Pharmaceuticals / West-Ward Pharmaceuticals indicated for rescue after high dose methotrexate therapy in osteosarcoma and for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists 8/16/2016
Nitrostat Pfizer Nitroglycerin Sublingual Tablets Dr. Reddy's Laboratories used to stop or prevent angina (chest pain). 8/29/2016
Wellbutrin XL Valeant Bupropion Hydrochloride Extended-Release Tablets (XL) Cipla an antidepressant used to treat Major Depressive Disorder (MDD) and Seasonal Affective Disorder (SAD)  8/30/2016
Enablex Allergan Darifenacin Extended-Release Tablets Cipla indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency 9/2/2016
Wellbutrin SR GlaxoSmithKline Bupropion HCI Extended-Release Tablets Dr. Reddy's Laboratories an antidepressant used to treat Major Depressive Disorder (MDD) and Seasonal Affective Disorder (SAD)  9/2/2016
Razadyne Johnson & Johnson Galantamine Tablets Hikma Pharmaceuticals / West-Ward Pharmaceuticals indicated for the treatment of mild to moderate dementia in patients with Alzheimer's disease 9/2/2016
Ortho-Cyclen 28 Ortho-McNeil Femynor Amneal indicated for use by females of reproductive potential to prevent pregnancy 9/8/2016
Cubicin Merck Sharp & Dohme Daptomycin for Injection Teva indicated for treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates 9/15/2016
Zemplar Abbvie Paricalcitol Injection Dr. Reddy's Laboratories used for the prevention and treatment of high levels of parathyroid hormone in certain patients with chronic kidney disease 9/19/2016
Cubicin Merck Daptomycin for Injection Fresenius Kabi USA indicated for treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates 9/20/2016
Metadate CD UCB Methylphenidate Hydrochloride Extended-Release Capsules Impax Laboratories indicated for treatment of Attention Deficit Hyperactivity Disorder (ADHD) 9/22/2016
Zegerid Santarus Omeprazole / Sodium Bicarbonate Powder for Oral Suspension Ajanta short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE 9/26/2016
Cymbalta Eli Lilly Duloxetine Capsules Camber Pharmaceuticals used to treat depression and anxiety 9/27/2016
Epzicom GlaxoSmithKline Abacavir / Lamivudine Tablets Teva indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, abacavir and lamivudine tablets may help to: Reduce the amount of HIV-1 in affected patients' blood (viral load), and increase the number of CD4+ (T) cells in affected patients' blood to help fight off other infections 9/29/2016
Fortamet Watson Metformin Hydrochloride Extended-Release Tablets Mylan indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 9/30/2016

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