FDA.reportPublic FDA data

Application 091657

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

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
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent
67457-197Tranexamic Acidtranexamic acidMylan Institutional LLCANDACurrent