FDA.reportPublic FDA data

Application 209860

Type
ANDA
Sponsor
APOTEX

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
60505-6169Tranexamic Acidtranexamic acidApotex Corp.ANDACurrent
60505-6169Tranexamic Acidtranexamic acidApotex Corp.ANDACurrent
60505-6169Tranexamic Acidtranexamic acidApotex Corp.ANDACurrent
60505-6169Tranexamic Acidtranexamic acidApotex Corp.ANDACurrent