← FDA DRUG APPROVALS

FDA NDA · NDA022430

TRANEXAMIC ACID

Sponsor: J MOLNER

APPLICATION
NDA022430
TYPE
NDA
ORIGINAL APPROVAL
2009-11-13
LATEST ACTION
2020-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LYSTEDA · ReferencePrescription
TRANEXAMIC ACID 650MG · TABLET · ORAL

Approval history

2020-12-07Labeling · Supplement 9 · standard — Letter ↗AP
2016-05-23Manufacturing (CMC) · Supplement 6 · priorityAP
2015-10-23Manufacturing (CMC) · Supplement 5 · priorityAP
2013-10-03Labeling · Supplement 4 · standard — Label ↗AP
2013-08-21Labeling · Supplement 3 · standard — Letter ↗AP
2011-04-06Labeling · Supplement 2 · standard — Review ↗AP
2009-11-13Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →