APPLICATION
ANDA205035
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-14
LATEST ACTION
2026-04-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2026-04-28Labeling · Supplement 12 · standardAP
2021-04-06Labeling · Supplement 4 · standardAP
2020-12-10Labeling · 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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