APPLICATION
ANDA202755
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-25
LATEST ACTION
2021-04-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRANEXAMIC ACIDDiscontinued
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2021-04-14Labeling · Supplement 4 · standardAP
2020-11-18Labeling · Supplement 3 · standardAP
2018-09-12Manufacturing (CMC) · Supplement 1 · unknownAP
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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