FDA.reportPublic FDA data

Application 065185

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLEOMYCIN SULFATEBLEOMYCIN SULFATEINJECTABLE;INJECTIONEQ 15 UNITS BASE/VIALNoYes
002BLEOMYCIN SULFATEBLEOMYCIN SULFATEINJECTABLE;INJECTIONEQ 30 UNITS BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-136BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCANDACurrent
63323-136BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCANDACurrent
63323-137BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCANDACurrent
63323-137BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCANDACurrent