New and Generic Drug Approvals

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March 25, 2014

Drug NameActive Ingredient Dosage Form/RouteSponsor Submission Type
Acephenacetaminophen Suppository;RectalG and W Labs Labeling Revision
Adrenaclickepinephrine Injectable;Intramuscular, SubcutaneousAmedra Pharms Manufacturing Change or Addition
Emtrivaemtricitabine Capsule;OralGilead Manufacturing Change or Addition
Estrogelestradiol Gel, Metered;TransdermalAscend Labeling Revision
Estrogelestradiol Gel;TopicalAscend Labeling Revision
Femhrtethinyl estradiol; norethindrone acetate Tablet;OralWarner Chilcott Llc Manufacturing Change or Addition
Firmagondegarelix acetate Powder;SubcutaneousFerring Manufacturing Change or Addition
Fludarabine Phosphatefludarabine phosphate Injectable;InjectionSandoz Manufacturing Change or Addition
Incivektelaprevir Tablet;OralVertex Pharms Manufacturing Change or Addition
Metro I.V. In Plastic Containermetronidazole Injectable;InjectionB Braun Manufacturing Change or Addition
Synarelnafarelin acetate Spray, Metered;NasalGd Searle Llc Manufacturing Change or Addition
Twinject 0.15epinephrine Injectable;Intramuscular, SubcutaneousAmedra Pharms Manufacturing Change or Addition
Twinject 0.3epinephrine Injectable;Intramuscular, SubcutaneousAmedra Pharms Manufacturing Change or Addition
Versaclozclozapine Suspension;OralJazz Pharms Iii Manufacturing Change or Addition
Viagrasildenafil citrate Tablet;OralPfizer Ireland Manufacturing Change or Addition
Zenpeppancrelipase (amylase;lipase;protease) Capsule, Delayed Release;OralAptalis Pharma Us Manufacturing Change or Addition

 

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