Feb 192016
 

February 19, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cefotaxime Sodium cefotaxime sodium Injectable;Injection Hospira Inc Approval
Depakote divalproex sodium Tablet, Delayed Release;Oral Abbvie Labeling Revision
Donepezil Hydrochloride donepezil hydrochloride Tablet;Oral Dexcel Pharma Approval
Gilenya fingolimod Capsule;Oral Novartis Labeling Revision
Humulin N insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Ibrance palbociclib Capsule;Oral Pfizer Inc Efficacy Supplement with Clinical Data to Support
Makena hydroxyprogesterone caproate Solution;Intramuscular Lumara Health Inc Manufacturing Change or Addition
Mysoline primidone Tablet;Oral Valeant Manufacturing Change or Addition
Nuvaring ethinyl estradiol; etonogestrel Ring;Vaginal Organon Usa Inc Manufacturing Change or Addition
Prezista darunavir ethanolate Tablet;Oral Janssen Prods Manufacturing Change or Addition
Primaxin cilastatin sodium; imipenem Powder;Intravenous Merck Manufacturing Change or Addition
Stribild cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Sumatriptan sumatriptan Spray;Nasal Lannett Approval
Tuzistra Xr chlorpheniramine polistirex; codeine polistirex Suspension, Extended Release;Oral Vernalis R and D Ltd Manufacturing Change or Addition