FDA.reportPublic FDA data

Application 212360

Type
ANDA
Sponsor
CAPLIN

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
43066-008TRANEXAMIC ACIDtranexamic acidBaxter Healthcare CorporationANDACurrent
43066-008TRANEXAMIC ACIDtranexamic acidBaxter Healthcare CorporationANDACurrent
43066-008TRANEXAMIC ACIDtranexamic acidBaxter Healthcare CorporationANDACurrent
43066-008TRANEXAMIC ACIDtranexamic acidBaxter Healthcare CorporationANDACurrent
43066-008TRANEXAMIC ACIDtranexamic acidBaxter Healthcare CorporationANDACurrent
65145-106Tranexamic AcidTranexamic AcidCaplin Steriles LimitedANDACurrent
65145-106Tranexamic AcidTranexamic AcidCaplin Steriles LimitedANDACurrent
65145-106Tranexamic AcidTranexamic AcidCaplin Steriles LimitedANDACurrent