APPLICATION
NDA019281
TYPE
NDA
ORIGINAL APPROVAL
1986-12-30
LATEST ACTION
2025-08-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYKLOKAPRON · ReferencePrescription
TRANEXAMIC ACID 100MG/ML · INJECTABLE · INJECTION
Approval history
2016-11-03Manufacturing (CMC) · Supplement 38 · standardAP
2016-08-01Manufacturing (CMC) · Supplement 40 · standardAP
2016-02-01Manufacturing (CMC) · Supplement 37 · standardAP
2015-10-20Manufacturing (CMC) · Supplement 36 · standardAP
2015-06-01Manufacturing (CMC) · Supplement 35 · standardAP
2015-04-17Manufacturing (CMC) · Supplement 34 · standardAP
2002-05-15Manufacturing (CMC) · Supplement 19 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 18 · standardAP
2001-11-02Manufacturing (CMC) · Supplement 17 · standardAP
2001-11-02Manufacturing (CMC) · Supplement 16 · standardAP
2001-10-31Labeling · Supplement 15 · standardAP
2001-07-31Manufacturing (CMC) · Supplement 12 · standardAP
2000-04-28Manufacturing (CMC) · Supplement 11 · standardAP
1999-11-15Manufacturing (CMC) · Supplement 10 · standardAP
1996-12-05Manufacturing (CMC) · Supplement 3 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 8 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 4 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 7 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 5 · standardAP
1994-11-07Manufacturing (CMC) · Supplement 6 · standardAP
1994-11-07Manufacturing (CMC) · Supplement 2 · standardAP
1986-12-30Type 3 - New Dosage Form · 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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