Ticlid

NDA 19979, held by Roche Palo. Ticlopidine Hydrochloride.

As of Nov 13, 2026, NDA 19979 (Ticlid), held by Roche Palo, was first approved by FDA on Oct 31, 1991, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1991
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Apr 18, 2001	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 31, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ticlid125MG · tablet;oral	Ticlopidine Hydrochloride	Discontinued
Ticlid250MG · tablet;oral	Ticlopidine Hydrochloride	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 9, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 18, 2001	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jun 14, 2000	Supplement 19Labeling · Priority review	Approved	Review
Jul 28, 1999	Supplement 17Labeling · Priority review	Approved	None posted
Apr 27, 1998	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 3, 1998	Supplement 14Manufacturing · Priority review	Approved	None posted
Aug 21, 1997	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 24, 1997	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 18, 1996	Supplement 10Manufacturing · Priority review	Approved	None posted
Jan 25, 1995	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 25, 1995	Supplement 9Labeling · Priority review	Approved	None posted
May 5, 1994	Supplement 1Manufacturing · Priority review	Approved	None posted
Mar 24, 1993	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 16, 1992	Supplement 5Labeling · Priority review	Approved	None posted
Dec 10, 1992	Supplement 3Labeling · Priority review	Approved	None posted
Oct 31, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19979
Drugs@FDA: Overview at FDA
Company: Roche Palo Alto

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters