| 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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