APPLICATION
ANDA201885
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-10
LATEST ACTION
2023-07-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2023-07-20Labeling · Supplement 10 · standardAP
2021-01-25Labeling · Supplement 7 · standardAP
2019-03-06Labeling · Supplement 6 · standardAP
2015-12-21Labeling · Supplement 3 · standardAP
2015-12-21Labeling · Supplement 2 · standardAP
2011-08-10Not Applicable · 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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