Gabitril

NDA 20646, held by Cephalon. Tiagabine Hydrochloride.

As of Nov 13, 2026, NDA 20646 (Gabitril), held by Cephalon, was first approved by FDA on Sep 30, 1997, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1997
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Sep 30, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

8 strengths and forms

Product	Active ingredient	Marketing
Gabitril4MG · tablet;oral	Tiagabine Hydrochloride	RxReference drug
Gabitril12MG · tablet;oral	Tiagabine Hydrochloride	RxReference drug
Gabitril16MG · tablet;oral	Tiagabine Hydrochloride	RxReference drug
Gabitril20MG · tablet;oral	Tiagabine Hydrochloride	Discontinued
Gabitril2MG · tablet;oral	Tiagabine Hydrochloride	RxReference drug
Gabitril6MG · tablet;oral	Tiagabine Hydrochloride	Discontinued
Gabitril8MG · tablet;oral	Tiagabine Hydrochloride	Discontinued
Gabitril10MG · tablet;oral	Tiagabine Hydrochloride	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 3, 2023	Supplement 23Labeling · Standard review	Approved	Label Letter
Aug 9, 2016	Supplement 21Labeling · Standard review	Approved	Label Letter
Nov 4, 2015	Supplement 18Labeling · Standard review	Approved	Medication Guide Label Letter
Jan 25, 2012	Supplement 20REMS	Approved	Letter
Oct 11, 2010	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 16Labeling	Approved	Label Letter
Nov 29, 2005	Supplement 15Manufacturing · Standard review	Approved	Letter Label
Feb 14, 2005	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 3, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 3, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 27, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
May 17, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 23, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 16, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 16, 1999	Supplement 5Labeling · Standard review	Approved	None posted
Jul 31, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
May 8, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 9, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 30, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20646
Drugs@FDA: Overview at FDA
Company: Cephalon

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