| 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 |
