FDA.reportPublic FDA data

Application 213948

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INHNoNo
002FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INHNoNo
003FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.5MG/INH;EQ 0.05MG BASE/INHNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7516fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7516fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7517fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7517fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7518fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7518fluticasone propionate and salmeterolfluticasone propionate and salmeterolTeva Pharmaceuticals USA, Inc.ANDACurrent