FDA.reportPublic FDA data

Application 076263

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLORASONE DIACETATEDIFLORASONE DIACETATECREAM;TOPICAL0.05%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0353Diflorasone Diacetatediflorasone diacetateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0353Diflorasone Diacetatediflorasone diacetateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
10337-395ApexiCon Ediflorasone diacetatePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent
10337-395ApexiCon Ediflorasone diacetatePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent
10337-395ApexiCon Ediflorasone diacetatePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent
62559-365ApexiCon Ediflorasone diacetateANI Pharmaceuticals, Inc.ANDACurrent