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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Aggrenox Boehringer Ingelheim Aspirin / Extended-Release Dipyridamole Capsules Teva reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis 7/1/2015
Axert Janssen Almotriptan Malate Tablets Teva acute treatment of migraine attacks in adults with a history of migraine with or without aura; acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more 7/8/2015
Targretin Valeant Bexarotene Mylan treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy 7/9/2015
Namenda Forest Labs Memantine Hydrochloride Tablets Amneal Pharms treatment of moderate to severe dementia of the Alzheimer's type 7/11/2015
Namenda Merz Pharma Memantine Hydrochloride Tablets Dr. Reddy's Labs treatment of moderate to severe dementia of the Alzheimer's type 7/12/2015
Tobi Novartis Tobramycin Inhalation Solution Amneal Pharms for the management of cystic fibrosis patients with Pseudomonas aeruginosa 7/13/2015
Namenda Forest Labs Memantine Hydrochloride Tablets Mylan  treatment of moderate to severe dementia of the Alzheimer's type 7/14/2015
Angiomax The Medicines Company Bivalirudin for Injection Hospira indicated as an anticoagulant 7/16/2015
Pulmicort AstraZeneca Budesonide Inhalation Suspension Sandoz indicated for maintenance treatment of asthma and as a prophylactic therapy in children 12 months to 8 years of age 7/28/2015
Megace ES E. R. Squibb & Sons Megestrol Acetate, USP, Oral Suspension Par Pharm indicated for the treatment of anorexia, cachexia, or an unexplained significant weigh loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) 7/29/2015
Sodium Edecrin Alton Pharma Ethrynate Sodium for Injection USP Par Pharm treatment of edema 8/4/2015
Nexium AstraZeneca Esomeprazole Magnesium Delayed-Release Capsules Mylan treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older 8/5/2015
Lidoderm Endo Pharm Lidocaine Patch 5% Mylan indicated for relief of pain associated with post-herpetic neuralgia 8/10/2015
Mirapex ER Boehringer Ingelheim Pramipexole Dihydrochloride ER Tablets Dr. Reddy's Labs treatment for Parkinson's disease 8/11/2015
Xenazine Valeant Tetrabenazine Sun Pharm
 treatment
of chorea associated with Huntington’s disease.
8/17/2015
Abilify Bristol-Myers Squibb Aripiprazole Oral Solution Amneal Pharms add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age. 8/18/2015
Abilify Bristol-Myers Squibb Aripiprazole Oral Solution Silarx Pharms add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy. Treatment of manic or mixed episodes associated with Bipolar I Disorder I adults and in pediatric patients 10 to 17 years of age. Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age. Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age. Treatment of Tourette's Disorder in pediatric patients 6 to 18 years of age. 8/18/2015
Yaz Bayer HealthCare Drospirenone / Ethinyl Estradiol Tablets Glenmark Pharms prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 8/19/2015
Zosyn Pfizer Piperacillin / Tazobactam for Injection Mylan indicated for treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria 8/25/2015
Dibenzyline WellSpring Pharms Phenoxybenzamine Hydrochloride Capsules Roxane Labs treating high blood pressure and sweating caused by a certain kind of tumor (pheochromocytoma) 8/25/2015
Exelon Novartis Rivastigmine Transdermal System Alvogen treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease. 8/31/2015
Exelon Novartis Rivastigmine Transdermal System Sandoz treatment of mild, moderate, and severe dementia of the Alzheimer’s type, and mild to moderate dementia associated with Parkinson’s disease. 8/31/2015
Cymbalta DR Eli Lilly and Co. Duloxetine DR Capsules Lupin Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathic Pain; Chronic Musculoskeletal Pain 9/3/2015
Vfend PF Prism Voriconazole Tablets Glenmark Pharms treating certain fungal infections 9/4/2015
Yasmin Bayer Drospirenone / Ethinyl Estradiol Tablets Mylan indicated for use by women to prevent pregnancy 9/8/2015
Unasyn Pfizer Ampicillin / Sulbactam for Injection Mylan indicated for the treatment of infections due to susceptible strains of designated microorganisms in skin and skin structure infections, intra-abdominal infections and gynecological infections 9/14/2015
Lescol XL Novartis Fluvastatin Sodium ER Tablets Mylan indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride and increase HDL-C in adults with primary hypercholesterolemia and mixed dyslipidemia 9/18/2015
BenzaClin Valeant Phosphate 1% / Benzoyl Peroxide 5% Perrigo indicated for the topical treatment of acne vulgaris 9/22/2015
Invega Janssen Paliperidone ER Tablets Allergan treatment of schizophrenia in adults and adolescents (12-17 years of age) 9/25/2015
Invega Janssen Paliperidone ER Tablets Patriot Pharm treatment of schizophrenia in adults and adolescents (12-17 years of age) 9/25/2015
Nexium AstraZeneca Esomeprazole Magnesium DR Capsules Dr. Reddy's Labs treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older 9/28/2015
Invega Janssen Paliperidone ER Tablets Mylan treatment of schizophrenia in adults and adolescents (12-17 years of age) in addition to schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants in adults 9/28/2015
Orap Teva Pimozide Par Pharm antipsychotic indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment 9/30/2015

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