FDA.reportPublic FDA data

Application 203433

Type
ANDA
Sponsor
HIKMA

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
0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0326fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0327fluticasone propionate and salmeterolfluticasone propionate and salmeterolHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68763SUPPL2021-09-24