FDA.reportPublic FDA data

Application 075430

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBETASOL PROPIONATE (EMOLLIENT)CLOBETASOL PROPIONATECREAM;TOPICAL0.05%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0301Clobetasol Propionate (emollient)clobetasol propionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0301Clobetasol Propionate (emollient)clobetasol propionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0301Clobetasol Propionate (emollient)clobetasol propionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
10337-301TEMOVATE Eclobetasol propionatePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22472ORIG2003-04-30
30882ORIG1999-05-26