FDA.reportPublic FDA data

Application 076303

Type
ANDA
Sponsor
HOSPIRA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent
0409-4688Fluconazole in Sodium ChlorideFluconazole in Sodium ChlorideHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31108ORIG2004-07-30