APPLICATION
ANDA091657
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-03
LATEST ACTION
2022-06-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2022-06-23Labeling · Supplement 10 · standardAP
2020-10-19Labeling · Supplement 9 · standardAP
2018-05-14Labeling · Supplement 6 · standardAP
2015-09-29Labeling · Supplement 2 · standardAP
2011-11-03UNKNOWN · 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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