FDA.reportPublic FDA data

Application 206634

Type
ANDA
Sponsor
AKORN

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
17478-017Tranexamic AcidTranexamic AcidAkorn, Inc.ANDACurrent
17478-017Tranexamic AcidTranexamic AcidAkorn, Inc.ANDACurrent
17478-017Tranexamic AcidTranexamic AcidAkorn, Inc.ANDACurrent
17478-017Tranexamic AcidTranexamic AcidAkornANDACurrent
17478-017Tranexamic AcidTranexamic AcidAkorn, Inc.ANDACurrent