FDA.reportPublic FDA data

Application 076766

Type
ANDA
Sponsor
BAXTER HLTHCARE

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
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6045FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
0338-6046FluconazoleFluconazoleBaxter Healthcare CorporationANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-003Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
70655-002Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideRenaissance SSA, LLCANDACurrent
70655-088Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideRenaissance SSA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31163ORIG2004-07-30