APPLICATION
ANDA206713
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-27
LATEST ACTION
2026-07-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2026-07-02Labeling · Supplement 6 · standardAP
2021-06-24Labeling · Supplement 4 · standardAP
2020-11-18Labeling · Supplement 3 · standardAP
2018-04-26Labeling · 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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