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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Reclast Novartis Zoledronic Acid Injection Dr. Reddy's Laboratories osteoporosis 4/3/2013
Zovirax Ointment Valeant Pharma. Int'l Acyclovir Ointment USP, 5% Mylan management of initial genital herpes 4/3/2013
Zovirax Valeant Pharma. Int'l Acyclovir 5% Ointment Actavis Inc (ACT) management of initial genital herpes 4/5/2013
Zovirax Valeant Pharma. Int'l Acyclovir 5% Tape Actavis Inc (ACT) treatment of inflammation and itching 4/5/2013
Seasonique Tablets Teva Levonorgestrel / Ethinyl estradiol Lupin Pharmaceuticals use by women to prevent pregnancy 4/12/2013
Lysteda Ferring Tranexamic Acid Prasco cyclic heavy menstrual bleeding 5/1/2013
Zomig AstraZeneca Zolmitriptan Glenmark Generics Inc. acute treatment of migraine headaches in adults 5/15/2013
Zomig ZMT AstraZeneca Zolmitriptan ODT Glenmark Generics Inc. acute treatment of migraine headaches in adults 5/15/2013
Zomig Tablets IPR Pharmaceuticals Zolmitriptan Tablets Mylan acute treatment of migraine with or without aura in adults 5/15/2013
Zomig AstraZeneca Zolmitriptan Apotex acute treatment of migraine headaches in adults 5/15/2013
Zomig-ZMT AstraZeneca Zolmitriptan ODT Apotex acute treatment of migraine headaches in adults 5/15/2013
Tricor Tablets Abbvie Fenofibrate Tablets Mylan adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia 5/17/2013
Atacand AstraZeneca Candesartan Cilexetil Tablets Sandoz heart failure in adults with left ventricular systolic dysfunction, and hypertension in adults and children 1 to 17 years of age 5/22/2013
Sanctura XR Allergan Trospium Chloride Perrigo Co (PRGO) bladder dysfunction 5/29/2013
Depo-Testosterone Injection Pfizer Testosterone Cypionate Injection Sun Pharma replacement therapy in the male associated with symptoms of deficiency or absence of endogenous testosterone 6/4/2013
Rilutek Covis Pharma Riluzole Tablets Glenmark Generics treatment of amyotrophic lateral sclerosis 6/19/2013
Lamictal XR GlaxoSmithKline Lamotrigine Extended-Release Dr. Reddy's Laboratories seizure disorders and bipolar disorders 6/25/2013
Micronor Tablets Janssen Pharmaceuticals Norethindrone Tablets Mylan prevention of pregnancy 6/26/2013

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