APPLICATION
ANDA202436
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-11
LATEST ACTION
2023-06-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2023-06-27Labeling · Supplement 7 · standardAP
2022-04-29Labeling · Supplement 6 · standardAP
2020-10-29Labeling · Supplement 5 · standardAP
2019-09-13Labeling · Supplement 3 · standardAP
2014-02-11UNKNOWN · 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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