Feb 242016
 

February 24, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aczone dapsone Gel; Topical Allergan Approval
Anoro Ellipta umeclidinium bromide; vilanterol trifenatate Powder;Inhalation Glaxosmithkline Labeling Revision
Depo-Provera medroxyprogesterone acetate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Fosrenol lanthanum carbonate Tablet, Chewable;Oral Shire Llc Labeling Revision
Fosrenol lanthanum carbonate Powder;Oral Shire Dev Llc Labeling Revision
Incruse Ellipta umeclidinium bromide Powder;Inhalation Glaxo Grp England Efficacy Supplement with Clinical Data to Support
Lamotrigine lamotrigine Tablet, Orally Disintegrating;Oral Sciegen Pharms Inc Tentative Approval
Paricalcitol paricalcitol Capsule;Oral Lotus Pharm Co Ltd Approval
Qutenza capsaicin Patch;Topical Acorda Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Solution;Irrigation Baxter Hlthcare Manufacturing Change or Addition
Ultravate halobetasol propionate Cream;Topical Ranbaxy Manufacturing Change or Addition