FDA.reportPublic FDA data

Application 201885

Type
ANDA
Sponsor
AM REGENT

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
0517-0960Tranexamic Acidtranexamic acidAmerican Regent, Inc.ANDACurrent
0517-0960Tranexamic Acidtranexamic acidAmerican Regent, Inc.ANDACurrent
0517-0960Tranexamic AcidTranexamic AcidAmerican Regent, Inc.ANDACurrent