| 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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