APPLICATION
ANDA203521
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-12
LATEST ACTION
2023-09-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2023-09-12Labeling · Supplement 15 · standardAP
2020-08-11Labeling · Supplement 13 · standardAP
2019-06-28Labeling · Supplement 10 · standardAP
2014-08-12UNKNOWN · 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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