APPLICATION
NDA019979
TYPE
NDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2001-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TICLIDDiscontinued
TICLOPIDINE HYDROCHLORIDE 250MG · TABLET · ORAL
TICLIDDiscontinued
TICLOPIDINE HYDROCHLORIDE 125MG · TABLET · ORAL
Approval history
2001-11-09Manufacturing (CMC) · Supplement 20 · priorityAP
1999-07-28Labeling · Supplement 17 · priorityAP
1998-04-27Manufacturing (CMC) · Supplement 13 · priorityAP
1998-02-03Manufacturing (CMC) · Supplement 14 · priorityAP
1997-08-21Manufacturing (CMC) · Supplement 12 · priorityAP
1997-02-24Manufacturing (CMC) · Supplement 11 · priorityAP
1996-10-18Manufacturing (CMC) · Supplement 10 · priorityAP
1995-01-25Manufacturing (CMC) · Supplement 8 · priorityAP
1995-01-25Labeling · Supplement 9 · priorityAP
1994-05-05Manufacturing (CMC) · Supplement 1 · priorityAP
1993-03-24Manufacturing (CMC) · Supplement 7 · priorityAP
1992-12-16Labeling · Supplement 5 · priorityAP
1992-12-10Labeling · Supplement 3 · priorityAP
1991-10-31Type 1 - New Molecular Entity · Original · priorityAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.