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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Diamox Teva Acetazolamide IR Tablets Heritage Pharmaceuticals indicated for the treatment of glaucoma, epilepsy, mountain sickness and fluid retention 1/4/2017
Emend Merck Sharp & Dohme Aprepitant Capsules Sandoz prescribed for patients 12 years of age or older, in combination with other antiemetic agents to help prevent nausea and vomiting caused by certain chemotherapy medicines and for adults to prevent nausea and vomiting after surgery 1/4/2017
MS Contin ER Purdue Pharma Morphine Sulfate ER Tablets Lupin indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate 1/13/2017
Pacerone Upsher-Smith Laboratories Amiodarone Tablets Mayne Pharma indicated for life-threatening recurrent ventricular arrhythmia 1/13/2017
Ortho-Cyclen 28 Janssen Norgestimate / Ethinyl Estradiol Tablets Lupin indicated for use by females of reproductive potential to prevent pregnancy 1/24/2017
Lotronex Promethius Laboratories Alosetron Hydrochloride Tablets Amneal Pharmaceuticals indicated for women with severe diarrhea-predominant irritable bowel syndrome (IBS) 1/30/2017
Integrilin Merck Eptifibatide Injection Amneal Pharmaceuticals used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries)  1/31/2017
Imdur Schering Isosorbide Mononitrate ER Tablets Heritage Pharmaceuticals indicated for the prevention of angina pectoris due to coronary artery disease 1/31/2017
Versed Hoffman-La Roche Midazolam Injection Heritage Pharmaceuticals used as an agent for preoperative sedation 1/31/2017
Tricor AbbVie Fenofibrate Tablets Camber Pharmaceuticals  reduce cholesterol and triglycerides in the blood 2/1/2017
Bupap ECR Pharmaceuticals Butalbital Acetaminophen (APAP) Tablets Mayne Pharma indicated for treatment of tension headache (migraine) 2/16/2017
Ritalin LA Novartis Methylphenidate ER Capsules Mayne Pharma indicated for attention deficit hyperactivity disorder (ADHD) 2/21/2017
Pristiq Pfizer Desvenlafaxine Succinate ER Tablets Breckenridge indicated for treatment of major depressive disorder (MDD) 3/1/2017
Temovate Fougera Pharmaceuticals Clobetasol Propionate Scalp Application Lupin indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp 3/1/2017
Pristiq ER Pfizer Desvenlafaxine ER Tablets Teva indicated for treatment of major depressive disorder (MDD) 3/1/2017
Pristiq Wyeth Desvenlafaxine Succinate ER Tablets Lupin indicated for the treatment of major depressive disorder (MDD) 3/2/2017
Paxil CR Apotex Paroxetine ER Tablets Lupin treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder 3/7/2017
Women's Rogaine 5% Minoxidil Foam (OTC) Johnson & Johnson Store Brand Equivalent to Women's Rogaine Foam (OTC) Perrigo indicated to regrow hair on the top of the scalp 3/8/2017
Hydrocodone Bitartrate / Acetaminophen Tablets Mikart Hydrocodone Bitartrate / Acetaminophen Tablets Lupin indicated for the relief of moderate to moderately severe pain 3/9/2017
Pristiq Wyeth Desvenlafaxine Succinate ER Tablets Hikma indicated for the treatment of major depressive disorder (MDD) 3/10/2017
Pristiq Pfizer Desvenlafaxine ER Tablets Mylan indicated for the treatment of major depressive disorder (MDD) 3/10/2017
Aromasin Pfizer Exemestane Tablets Mylan indicated in the treatment of certain types of breast cancer in women after menopause 3/13/2017
Minastrin 24 Fe Allergan Ferrous Fumarate Tablets Lupin indicated for use by females of reproductive age to prevent pregnancy 3/16/2017
Minastrin 24 Fe Allergan Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Tablets Teva indicated for use by women to prevent pregnancy 3/16/2017
TOBI Novartis Tobramycin Inhalation Solution Lupin indicated for the management of cystic fibrosis patients with P. aeruginosa 3/23/2017
Eliphos Hawthorn Pharmaceuticals Calcium Acetate IR Tablets Heritage Pharmaceuticals indicated to reduce serum phosphorus in patients with end stage renal disease 3/27/2017
Xeloda Hoffman La Roche Capecitabine Tablets ACETO indicated for the treatment of metastatic breast cancer 3/28/2017
Fusilev Spectrum Pharmaceuticals Levoleucovorin for Injection Amneal Biosciences is a foliate analog indicated for rescue after high-dose methotrexate therapy for osteosarcoma and diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent over dosage of folic acid antagonists 3/28/2017
Merrem AstraZeneca Meropenem Injection Aurobindo Pharma USA indicated as single agent therapy for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections such as appendicitis and peritonitis, and bacterial meningitis 3/28/2017
Epzicom VIIV Healthcare Abacavir / Lamivudine Tablets Lupin indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection 3/29/2017
Epizcom VIIV Healthcare Abacavir Sulfate / Lamivudine Tablets Aurobindo Pharma USA indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection 3/30/2017
Zyflo CR Chiesi USA Zileuton ER Tablets ACETO indicated for the chronic treatment of asthma 3/31/2017

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