FDA.reportPublic FDA data

Application 078764

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoNo
002FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9666FluconazoleFluconazoleWest-Ward Pharmaceuticals CorpANDACurrent
0143-9666FluconazoleFluconazoleHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9667FluconazoleFluconazoleWest-Ward Pharmaceuticals CorpANDACurrent
0143-9667FluconazoleFluconazoleHikma Pharmaceuticals USA Inc.ANDACurrent