APPLICATION
ANDA208840
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2021-06-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRANEXAMIC ACIDPrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2021-06-24Labeling · Supplement 4 · standardAP
2021-06-24Labeling · Supplement 2 · standardAP
2018-05-14Labeling · Supplement 1 · standardAP
2017-02-28UNKNOWN · Original · standardAP
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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