FDA.reportPublic FDA data

Application 208891

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71467ORIG2022-06-28
57717ORIG2019-02-21
57452ORIG2019-02-06