APPLICATION
ANDA205228
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-17
LATEST ACTION
2026-03-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRANEXAMIC ACIDDiscontinued
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2026-03-18Labeling · Supplement 5 · standardAP
2022-06-17Labeling · Supplement 3 · standardAP
2018-05-14Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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