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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Focalin XR  Novartis Dexmethylphenidate HCl ER Capsules Impax Laboratories used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older 7/5/2017
Vigamox Novartis Moxifloxacin HCl Solution Lupin used for the treatment of bacterial conjunctivitis caused by susceptible strains of the organisms 7/5/2017
Axiron Eli Lilly Testosterone Topical Solution Perrigo used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone 7/5/2017
Concerta Janssen Methylphenidate HCl ER Tablets Impax Laboratories used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older 7/17/2017
Renvela Genzyme Sevelamer Carbonate Tablets Aurobindo Pharma USA used for the control of serum phosphorus in patients with chronic kidney disease 7/19/2017
Altace Pfizer Ramipril Capsules Rising Pharmaceuticals used for the treatment of hypertension 7/21/2017
Cozaar Merck Losartan Potassium Tablets Rising Pharmaceuticals used for the treatment of hypertension 7/21/2017
Hyzaar Merck Losartan Potassium / Hydrochlorothiazide Tablets Rising Pharmaceuticals used for the treatment of hypertension 7/21/2017
Pravachol Bristol-Myers Squibb Pravastatin Tablets Rising Pharmaceuticals  used as an adjunct to diets restricting saturated fats and cholesterol 7/21/2017
Temodar Schering Temozolomide Capsules Rising Pharmaceuticals used for the treatment of adult patients with newly diagnosed glioblastoma multiforme 7/21/2017
Zomig-ZMT AstraZeneca Zolmitriptan Orally Disintegrating Tablets Rising Pharmaceuticals used for the acute treatment of migraines 7/21/2017
Cetirizine HCl Capsules (Softgel) (OTC) Bionpharma Cetirizine HCl Capsules (Softgel) (OTC) Strides Shasun used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives and itching 7/24/2017
Vagifem Novo Nordisk Estradiol Vaginal Inserts Teva used for the treatment of atrophic vaginitis due to menopause 7/24/2017
Robinul Shionogi Glycopyrrolate Tablets Heritage Pharmaceuticals used for adjunctive therapy in the treatment of peptic ulcer 7/25/2017
Wellburin GlaxoSmithKline Bupropion Tablets Heritage Pharmaceuticals used for the treatment of depression 7/25/2017
Epiduo Galderma Laboratories Adapalene / Benzoyl Peroxide Gel Teva used for the topical treatment of acne vulgaris in patients 9 years of age and older 7/28/2017
Transderm Scop Sandoz Scopolamine 1.5 mg Transdermal System Patch Perrigo used for the prevention of nausea and vomiting associated with motion sickness and recovery from anesthesia after surgery in adults 7/31/2017
Tamiflu Roche Oseltamivir Phosphate Capsules Amneal used to treat and prevent influenza A and influenza B (flu) 8/8/2017
Roxicodone Mallinckrodt Oxycodone HCI Tablets Camber Pharmaceuticals used to help relieve moderate to severe pain 8/17/2017
Ziagen ViiV Healthcare Abacavir Oral Solution Camber Pharmaceuticals
used in combination with other
antiretroviral agents for the treatment of HIV-1 infection
8/17/2017
Axiron Eli Lilly Testosterone Topical Solution Teva used to treat adult males who have low or no testosterone due to certain medical conditions 8/18/2017
Seroquel XR AstraZeneca Quetiapine Fumarate ER Tablets Lupin used for the treatment of schizophrenia; acute manic or mixed episodes in bipolar I disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder 8/23/2017
Suprax Astellas Cefixime for Oral Suspension Dr. Reddy's Laboratories used in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: Uncomplicated Urinary Tract Infections; Otitis Media; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral) 8/28/2017
Sabril Lundbeck Vigabatrin for oral solution Endo used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss 8/28/2017
Relpax Pfizer Eletriptan Hydrobromide Tablets Ajanta used to treat migraines  8/31/2017
Fosrenol Shire Lanthanum Carbonate Chewable Tablets Lupin used to reduce serum phosphate in patients with end stage renal disease (ESRD) 8/31/2017
Oxycodone HCl Lehigh Valley Oxycodone HCl Tablets ANI Pharmaceuticals used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate 9/1/2017
Benicar Daiichi Sankyo Olmesartan Medoxomil Tablets Lupin used for the treatment of hypertension, alone or in combination with other antihypertensive agents, to lower blood pressure 9/4/2017
Skelaxin King Pharmaceuticals Metaxalone Tablets Dr. Reddy's Laboratories used as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions 9/6/2017
Wellbutrin XL  GlaxoSmithKline Bupropion HCl ER Tablets Dr. Reddy's Laboratories used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder) 9/6/2017
Cancidas Merck Caspofungin Acetate for Injection Fresenius Kabi USA used in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections; treatment of esophageal candidiasis and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies 9/12/2017
Urocit-K Mission Pharma Potassium Citrate ER Tablets Strides Shasun  used for preventing certain types of kidney stones 9/12/2017
Symmetrel Upsher-Smith Amantadine HCl IR Capsules Heritage Pharmaceuticals used for the treatment of influenza A virus infection and is also used in the treatment of Parkinson's 9/14/2017
Minastrin 24 FE Allergan Norethindrone Acetate / Ethinyl Estradiol Tablets / Ferrous Fumarate Tablets Mylan used for use by women to prevent pregnancy 9/14/2017
Lovaza SmithKline Beecham Omega-3-Acid Ethyl Esters Capsules Strides Shasun used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG) 9/20/2017
Nexium 24HR (OTC) AstraZeneca Esomeprazole Magnesium (OTC) Perrigo used to treat frequent heartburn (occurring 2 or more days a week) 9/27/2017
Minastrin 24 FE Allergan Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Capsules Amneal used for use by women to prevent pregnancy 9/28/2017
Renvela Genzyme Corp Sevelamer Carbonate Tablets Dr. Reddy's Laboratories used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis 9/29/2017
Gleevec Novartis Imatinib Mesylate Tablets Mylan used in newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, etc. 9/29/2017

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