USFDA: New and Generic Drug Approvals: 13 NOV 2014

New and Generic Drug Approvals

November 13, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ActemratocilizumabInjectable; InjectionGenentechLabeling Revision
Advair Diskus 100/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 250/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 500/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Hfafluticasone propionate; salmeterol xinafoateAerosol, Metered;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 100fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 250fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 50fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
MycobutinrifabutinCapsule;OralPharmacia and UpjohnLabeling Revision
ZolmitriptanzolmitriptanTablet;OralSun Pharma GlobalApproval

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