FDA.reportPublic FDA data

Application 076294

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLECREAM;TOPICAL2%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0099ketoconazoleketoconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0099ketoconazoleketoconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0099ketoconazoleketoconazoleE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
50090-0719ketoconazoleketoconazoleA-S Medication SolutionsANDACurrent
50090-0720ketoconazoleketoconazoleA-S Medication SolutionsANDACurrent
50090-0720ketoconazoleketoconazoleA-S Medication SolutionsANDACurrent
50436-4448ketoconazoleketoconazoleUnit Dose ServicesANDACurrent
61919-841KETOCONAZOLEKETOCONAZOLEDIRECT RXANDACurrent
61919-841KETOCONAZOLEKETOCONAZOLEDIRECT RXANDACurrent
70518-1637ketoconazoleketoconazoleREMEDYREPACK INC.ANDACurrent
70518-1637ketoconazoleketoconazoleREMEDYREPACK INC.ANDACurrent