FDA.reportPublic FDA data

Application 091596

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDINJECTABLE;INJECTION100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14789-500Tranexamic acidTRANEXAMIC ACIDNexus Pharmaceuticals IncANDACurrent
63323-563Tranexamic AcidTranexamic AcidFresenius Kabi USA, LLCANDACurrent
63323-563Tranexamic AcidTranexamic AcidFresenius Kabi USA, LLCANDACurrent
63323-563Tranexamic AcidTranexamic AcidFresenius Kabi USA, LLCANDACurrent