USFDA: New and Generic Drug Approvals: 17 NOV 2014

New and Generic Drug Approvals

November 17, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cutivatefluticasone propionateLotion;TopicalFougera PharmsManufacturing Change or Addition
Hepatamine 8%amino acidsInjectable;InjectionB BraunManufacturing Change or Addition
Nucyntatapentadol hydrochlorideSolution;OralJanssen PharmsLabeling Revision
Pegintronpeginterferon alfa-2bSyringeScheringLabeling Revision
Pegintronpeginterferon alfa-2bVialScheringLabeling Revision
Sylatronpeginterferon alfa-2bVialScheringLabeling Revision
Unasynampicillin sodium; sulbactam sodiumInjectable;InjectionPfizerLabeling Revision

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