FDA.reportPublic FDA data

Application 078718

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATEINJECTABLE;INJECTION500MG/VIALNoNo
002DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATEINJECTABLE;INJECTION2GM/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-597DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCANDACurrent
63323-597DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCANDACurrent
63323-599DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCANDACurrent
63323-599DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCANDACurrent