Feb 292016
 

February 29, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Depo-Subq Provera 104 medroxyprogesterone acetate Injectable;Subcutaneous Pharmacia and Upjohn Manufacturing Change or Addition
Effexor Xr venlafaxine hydrochloride Capsule, Extended Release;Oral Wyeth Pharms Inc Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Fluticasone Propionate fluticasone propionate Spray, Metered;Nasal Apotex Technologies Approval
Gonal-F follitropin alfa/beta Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Magnesium Sulfate magnesium sulfate Solution;Intramuscular, Intravenous Fresenius Kabi Usa Manufacturing Change or Addition
Qnasl beclomethasone dipropionate Aerosol, Metered;Nasal Teva Branded Pharm Manufacturing Change or Addition
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Labeling Revision
Tetracaine Hydrochloride tetracaine hydrochloride Solution;Ophthalmic Alcon Res Ltd Approval
Vaniqa eflornithine hydrochloride Cream;Topical Skinmedica Manufacturing Change or Addition