FDA.reportPublic FDA data

Application 212676

Type
ANDA
Sponsor
APOLLO

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
50090-5072tranexamic acidTranexamic AcidA-S Medication SolutionsANDACurrent
50090-5072tranexamic acidTranexamic AcidA-S Medication SolutionsANDACurrent
61990-0611tranexamic acidTranexamic AcidApollo Pharmaceuticals Inc.ANDACurrent
61990-0611tranexamic acidTranexamic AcidApollo Pharmaceuticals Inc.ANDACurrent
61990-0611tranexamic acidTranexamic AcidApollo Pharmaceuticals Inc.ANDACurrent
81284-611tranexamic acidTranexamic AcidProvepharm Inc.ANDACurrent
81284-611tranexamic acidTranexamic AcidProvepharm Inc.ANDACurrent
81284-612tranexamic acidTranexamic AcidProvepharm Inc.ANDACurrent
81284-612tranexamic acidTranexamic AcidProvepharm Inc.ANDACurrent