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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Femhrt Warner Chilcott Norethindrone Acetate and Ethinyl Estradiol Tablets Lupin indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis 4/5/2016
Epivir ViiV Healthcare Lamivudine Tablets Mylan indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection 4/6/2016
Lopressor Novartis Metoprolol Tartrate Tablets Mylan indicated for the treatment of hypertension 4/11/2016
Glucerna Asceptic Adult Nutritional Shake (OTC) Abbott Laboratories Glucerna Asceptic Adult Nutritional Shake (OTC) Perrigo nutritional shake for people with diabetes 4/12/2016
Zyvox Pfizer Linezolid Injection in Freeflex bags Fresenius Kabi USA indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial and Community-acquired pneumonia, Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, Uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecium infections 4/21/2016
BenzaClin Pump Topical Gel Valeant Pharmaceutical Clindamycin Phosphate 1% / Benzoyl Peroxide 5% Perrigo indicated for the topical treatment of acne vulgaris 5/2/2016
Mucinex DM ER Tablets (OTC) Reckitt Benckiser Guaifenesin / Dextromethorphan Hydrobromide ER Tablets (OTC) Perrigo indicated to control coughs and to break up mucus, making coughs more productive 5/3/2016
Apresoline Novartis Hydralazine Hydrochloride Injection Mylan treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure 5/5/2016
Lipofen Cipher Pharmaceuticals Fenofibrate Capsules ANI Pharmaceuticals indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia 5/9/2016
Frova Endo Pharms Frovatriptan Succinate Tablets Mylan treat acute migraine headaches in adults 5/12/2016
Rowasa Alaven Pharmaceuticals Mesalamine rectal suspension enema ANI Pharmaceuticals Inc. indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis 5/16/2016
Apresazide Novartis Hydralazine Hydrochloride Injection Mylan indicated for treatment of severe essential hypertension when the oral version of the drug cannot be given and there is in urgent need to lower blood pressure 5/16/2016
Doryx Mayne Doxycycline Hyclate Delayed-Release (DR) Tablets, 200 mg. Mylan indicated as adjunctive therapy for severe acne 5/23/2016
Flonase (OTC) GlaxoSmithKline Fluticasone 50 MCG Spray (OTC) Hikma indicated for the temporary relief of hay fever or for the upper respiratory allergies in adult and pediatric patients 4 years of age and older 5/31/2016
Flonase (OTC) GlaxoSmithKline Fluticasone Propionate Nasal Spray (OTC) Perrigo indicated for the temporary relief of hay fever or other upper respiratory allergies in adult and pediatric patients 4 years of age and older 5/31/2016
Doxteric Mayne Doxycycline Hyclate Delayed-Release (DR) Tablets, 50 mg. Mylan indicated as adjunctive therapy for severe acne 6/1/2016
Nuvigil Cephalon Armodafinil Tablets Mylan used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift-work disorder 6/1/2016
Rythmol SR GlaxoSmithKline Propafenone Hydrochloride ER Capsules Mylan indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease 6/2/2016
Vidaza Celgene Azacitidine for Injection Mylan indicated for the treatment of the five French-American-British (FAB) subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia 6/2/2016
Cleocin Pharmacia and Upjohn Clindamycin Palmitate Hydrochloride for Oral Solution Mylan indicated for treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives are inappropriate 6/3/2016
OxyIR Purdue Pharma Oxycodone HCI Capsules ANI Pharmaceuticals indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate 6/13/2016
Namenda Forest Laboratories Memantine Hydrochloride Tablets Ajanta Pharma anti-dementia drug 6/14/2016
Avodart GlaxoSmithKline Dutasteride Capsules Mylan indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery 6/24/2016
Imitrex GlaxoSmithKline Sumatriptan Injection Teva / Antares Pharma treat acute migraine with or without aura, and acute cluster headaches in adults 6/27/2016
Lutera 28 Alesse Larissia Amneal Pharmaceuticals oral contraception 6/29/2016

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