FDA.reportPublic FDA data

Application 079104

Type
ANDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoYes
002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-113FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-113FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent