FDA.reportPublic FDA data

Application 076065

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMCINONIDEAMCINONIDECREAM;TOPICAL0.1%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0278AmcinonideAmcinonideFougera Pharmaceuticals Inc.ANDACurrent
0168-0278AmcinonideAmcinonideFougera Pharmaceuticals Inc.ANDACurrent
0168-0278AmcinonideAmcinonideFougera Pharmaceuticals Inc.ANDACurrent