CDER New August 10, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

August 7, 2015


New and Generic Drug Approvals

August 6, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Asmanex Hfa mometasone furoate Aerosol, Metered;Inhalation Merck Sharp Dohme Manufacturing Change or Addition
Bio-Tropin somatropin recombinant Injectable;Injection Ferring Manufacturing Change or Addition
Climara estradiol Film, Extended Release;Transdermal Bayer Hlthcare Manufacturing Change or Addition
Commit nicotine polacrilex Troche/Lozenge;Oral Glaxosmithkline Cons Labeling Revision
Dulera formoterol fumarate; mometasone furoate Aerosol, Metered;Inhalation Merck Sharp Dohme Manufacturing Change or Addition
Nicoderm Cq nicotine Film, Extended Release;Transdermal Sanofi Aventis Us Labeling Revision
Solu-Medrol methylprednisolone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition
Zomacton somatropin recombinant Injectable;Injection Ferring Manufacturing Change or Addition

 


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