APPLICATION
ANDA091596
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-02
LATEST ACTION
2021-06-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRANEXAMIC ACIDDiscontinued
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2021-06-24Labeling · Supplement 5 · standardAP
2019-08-14Labeling · Supplement 4 · standardAP
2016-02-19Labeling · Supplement 2 · standardAP
2012-03-02Not 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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