FDA.reportPublic FDA data

Application 202286

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDTABLET;ORAL650MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3638Tranexamic AcidTranexamic AcidApotex Corp.ANDACurrent
60505-3638Tranexamic AcidTranexamic AcidApotex Corp.ANDACurrent
60505-3638Tranexamic AcidTranexamic AcidApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22883ORIG2016-07-29