FDA.reportPublic FDA data

Application 201580

Type
ANDA
Sponsor
XGEN PHARMS

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
39822-1000Tranexamic AcidTranexamic AcidX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-1000Tranexamic AcidTranexamic AcidXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-1000Tranexamic AcidTranexamic AcidXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-1000Tranexamic AcidTranexamic AcidX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-1001Tranexamic AcidTranexamic AcidXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-1001Tranexamic AcidTranexamic AcidX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-1001Tranexamic AcidTranexamic AcidX-GEN Pharmaceuticals, Inc.ANDACurrent
50090-4530Tranexamic AcidTranexamic AcidA-S Medication SolutionsANDACurrent
50090-4530Tranexamic AcidTranexamic AcidA-S Medication SolutionsANDACurrent