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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Sustiva Bristol-Myers Squibb Efavirenz Capsules Rising Pharms indicated for the treatment of HIV-1 infection in adults and pediatric patients 1/2/2018
Estrace Cream Allergan Estradiol Vaginal Cream Teva indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause 1/2/2018
Busulfex Otsuka Busulfan Injection Amneal indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia 1/4/2018
Ancobon Capsules Valeant Pharms Flucytosine Capsules Lupin indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus 1/5/2018
Entocort EC Perrigo Pharma Budesonide Capsules Amneal used to help prevent the symptoms of asthma 1/18/2018
Ifex Baxter Ifosfamide Injection West-Ward Pharms indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.  It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis 1/18/2018
Vibra-Tabs Tablet Pfizer Doxycycline  Hyclate Tablet Lupin indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne 1/19/2018
Epiduo Gel Galderma Labs Adapalene / Benzoyl Peroxide Gel Perrigo indicated for the topical treatment of acne vulgaris in patients 9 years of age and older 1/24/2018
Viread Tablets Gilead Sciences Tenofovir Disoproxil Fumarate Tablets Cipla indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older 1/29/2018
Viread Tablets Gilead Sciences Tenofovir Disoproxil Fumarate Tablets Strides indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and also indicated for the treatment of chronic hepatitis B in adults 1/29/2018
Accutane  Hoffmann-La Roche Isotretinoin Capsules Amneal indicated for the treatment of severe recalcitrant nodular acne 2/1/2018
Clobex Lotion Galderma Labs Clobetasol Propionate Lotion Lupin is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, in patients 18 years of age or older 2/1/2018
Sustiva Tablets Bristol-Myers Squibb Efavirenz Tablets Mylan indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg 2/1/2018
Niaspan AbbVie Niacin ER Tablets Aurobindo indicated to reduce elevated TC, LDL-C, Apo B and TG and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia and to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia 2/2/2018
Xenazine Valeant Pharms Tetrabenazine Tablets Dr. Reddy's Labs indicated for the treatment of
chorea associated with Huntington’s disease
2/2/2018
Concerta Janssen Methylphenidate HCl ER Tablets Amneal used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) 2/5/2018
Tenormin Alvogen Atenolol Tablets Rising Pharms indicated for hypertension 2/7/2018
Kapvay Tablets Concordia Int'l Clonidine HCl ER Tablets Lupin indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications 2/8/2018
Syprine Capsules Valeant Pharms Trientine HCl Capsules Teva is used in the treatment of patients with Wilson’s disease who are intolerant of penicillamine 2/9/2018
Tamiflu Capsules Hoffman-La Roche Oseltamivir Phosphate Capsules Lupin is indicated for the treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and prophylaxis of influenza A and B in patients 1 year and older 2/12/2018
Viread Tablets Gilead Sciences Tenofovir Disoproxil Fumarate Tablets Camber Pharms used to treat Hepatitis B and HIV Infection 2/13/2018
Copaxone Teva Glatopa Sandoz indicated for the treatment of patients with relapsing-forms of multiple sclerosis 2/13/2018
Treximet Pernix Ireland Sumatriptan / Naproxen Sodium Tablets Aurobindo indicated for the acute treatment of migraine attacks with or without aura in adults 2/15/2018
Celexa Forest Labs Citalopram Oral Solution Camber Pharms used to treat depression 2/16/2018
Solodyn ER Tablets Medicis Pharm Minocycline HCl ER Tablets Impax Labs is used to treat moderate to severe acne in people 12 years and older 2/20/2018
Solodyn ER Tablets Valeant Pharms Minocycline HCl ER Tablets Teva indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older 2/20/2018
Namenda XR Forest Labs Memantine HCl ER Capsules Amneal used to treat moderate to severe Alzheimer's type dementia 2/21/2018
Namenda XR Capsules Allergan Memantine HCl ER Capsules Lupin indicated for the treatment of moderate to severe dementia of the Alzheimer’s type 2/21/2018
Axiron Topical Solution Eli Lilly Testosterone Topical Solution Lupin indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone 2/26/2018
Zantac (OTC) Sanofi Ranitidine Tablets (OTC) Strides used to treat peptic ulcers of the stomach and intestines and gastroesophageal reflux and heartburn
related to indigestion
2/26/2018
Ritalin LA Capsules Novartis Methylphenidate ER Capsules Mayne Pharma indicated for Attention Deficit Hyperactivity Disorder (ADHD) 2/28/2018
Tamiflu Hoffman La Roche Oseltamivir Phosphate for Oral Suspension Amneal used for treating and preventing the flu 3/1/2018
Tamiflu Hoffman La Roche Oseltamivir Phosphate Capsules Camber Pharms used for treating and preventing the flu 3/8/2018
Gabitril Cephalon Tiagabine HCl Tablets Amneal used in the treatment of epilepsy 3/12/2018
Safyral Tablets Bayer Healthcare Tydemy Tablets Lupin indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception 3/13/2018
Sustiva Tablets Bristol-Myers Squibb Efavirenz Tablets Strides indicated for the treatment of Human Immunodeficiency Virus Type 1
(HIV-1) infected adults and adolescents
3/14/2018
Monodox Aqua Pharms Doxycycline Monohydrate IR Capsules Mayne Pharma indicated for the treatment of a number of infections, including
adjunctive therapy in severe acne
3/15/2018
Xyzal Allergy 24HR Tablets (OTC) Sanofi-Aventis Levocetirizine Dihydrochloride Tablets (OTC) Dr. Reddy's Labs used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing 3/16/2018
Mutamycin Bristol-Myers Squibb  Mitomycin for Injection Mylan used in combination with other cancer medicines in the treatment of stomach and pancreatic cancers 3/20/2018
Norvir Tablets AbbVie Ritonavir Tablets West-Ward Pharms for use in combination with other antiretroviral agents for treatment of human immunodeficiency virus (HIV-1) infection 3/20/2018
Aloxi Helsinn Healthcare Palonosetron HCl Injection Teva indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy 3/23/2018
Aloxi Helsinn Palonosetron HCl Injection Cipla indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy 3/26/2018
Aloxi Helsinn Healthcare Palonosetron HCl Injection Dr. Reddy's Labs indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and for prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy 3/26/2018
Lodosyn Tablets Aton Pharma Carbidopa Tablets Lupin indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication 3/26/2018
Quartette Teva Levonorgestrel / Ethinyl Estradiol Tablets / Ethinyl Estradiol Tablets Mayne Pharma indicated for the prevention of
pregnancy
3/26/2018
Lialda Nogra Pharma Mesalamine DR Tablets Teva indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis 3/26/2018
Baraclude Tablets Bristol-Myers Squibb Entecavir Tablets Breckenridge for the treatment of chronic hepatitis B virus infection in adults and children at least 2 year of age 3/27/2018
Clobex Spray Galderma Labs Clobetasol Propionate Spray Lupin indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older 3/29/2018
Motrin Oral Suspension Johnson and Johnson / McNeil Consumer Healthcare Ibuprofen Oral Suspension Aurobindo indicated for the reduction of fever, to relieve pain and to relieve the signs and symptoms of juvenile arthritis in pediatric patients. In adult patients, for the treatment of primary dysmenorrhea and to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis

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