← FDA DRUG APPROVALS

FDA NDA · NDA020646

TIAGABINE HYDROCHLORIDE

Sponsor: CEPHALON

APPLICATION
NDA020646
TYPE
NDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2023-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

GABITRILDiscontinued
TIAGABINE HYDROCHLORIDE 8MG · TABLET · ORAL
GABITRIL · ReferencePrescription
TIAGABINE HYDROCHLORIDE 2MG · TABLET · ORAL
GABITRIL · ReferencePrescription
TIAGABINE HYDROCHLORIDE 16MG · TABLET · ORAL
GABITRIL · ReferencePrescription
TIAGABINE HYDROCHLORIDE 4MG · TABLET · ORAL
GABITRILDiscontinued
TIAGABINE HYDROCHLORIDE 10MG · TABLET · ORAL
GABITRILDiscontinued
TIAGABINE HYDROCHLORIDE 6MG · TABLET · ORAL
GABITRILDiscontinued
TIAGABINE HYDROCHLORIDE 20MG · TABLET · ORAL
GABITRIL · ReferencePrescription
TIAGABINE HYDROCHLORIDE 12MG · TABLET · ORAL

Approval history

2023-03-03Labeling · Supplement 23 · standard — Letter ↗AP
2016-08-09Labeling · Supplement 21 · standard — Label ↗AP
2015-11-04Labeling · Supplement 18 · standard — Medication Guide ↗AP
2012-01-25REMS · Supplement 20 — Letter ↗AP
2010-10-11Labeling · Supplement 17 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 16 · 901 required — Label ↗AP
2005-11-29Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2005-02-14Labeling · Supplement 14 · standard — Letter ↗AP
2001-10-03Manufacturing (CMC) · Supplement 11 · standardAP
2001-10-03Manufacturing (CMC) · Supplement 10 · standardAP
2001-07-27Manufacturing (CMC) · Supplement 9 · standardAP
2000-05-17Manufacturing (CMC) · Supplement 7 · standardAP
2000-05-16Manufacturing (CMC) · Supplement 8 · standardAP
1999-08-23Manufacturing (CMC) · Supplement 6 · standardAP
1999-04-16Labeling · Supplement 5 · standardAP
1999-04-16Manufacturing (CMC) · Supplement 4 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 3 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 2 · standardAP
1997-10-09Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-30Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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