APPLICATION
ANDA202373
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-17
LATEST ACTION
2021-11-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2021-11-09Labeling · Supplement 2 · standardAP
2016-02-19Labeling · Supplement 1 · standardAP
2011-11-17UNKNOWN · OriginalAP
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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