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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020646
Company: CEPHALON

Medication Guide

Other Important Information from FDA

Products on NDA 020646

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	AB	Yes	Yes
GABITRIL	TIAGABINE HYDROCHLORIDE	12MG	TABLET;ORAL	Prescription	AB	Yes	No
GABITRIL	TIAGABINE HYDROCHLORIDE	16MG	TABLET;ORAL	Prescription	AB	Yes	No
GABITRIL	TIAGABINE HYDROCHLORIDE	20MG	TABLET;ORAL	Discontinued	None	No	No
GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	AB	Yes	No
GABITRIL	TIAGABINE HYDROCHLORIDE	6MG	TABLET;ORAL	Discontinued	None	No	No
GABITRIL	TIAGABINE HYDROCHLORIDE	8MG	TABLET;ORAL	Discontinued	None	No	No
GABITRIL	TIAGABINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020646_gabitril_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2023	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020646Orig1s023ltr.pdf
08/09/2016	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020646Orig1s021ltr.pdf
01/25/2012	SUPPL-20	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020646s020ltr.pdf
11/04/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020646Orig1s018ltr.pdf
10/11/2010	SUPPL-17	REMS-Proposal, Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020646s017ltr.pdf
04/23/2009	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020646s016ltr.pdf
11/29/2005	SUPPL-15	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s015ltr.pdf
02/14/2005	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s014ltr.pdf
10/03/2001	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/03/2001	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/27/2001	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/16/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/17/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/1999	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/16/1999	SUPPL-5	Labeling		Label is not available on this site.
04/16/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/31/1998	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/1998	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/09/1997	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020646

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2016	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf
11/04/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf
10/11/2010	SUPPL-17	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf
10/11/2010	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf
04/23/2009	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf
11/29/2005	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf
02/14/2005	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf

Therapeutic Equivalents for NDA 020646

GABITRIL

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	214816	MSN
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	077555	SUN PHARM INDS

TABLET;ORAL; 12MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	12MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	12MG	TABLET;ORAL	Prescription	No	AB	214816	MSN

TABLET;ORAL; 16MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	16MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	16MG	TABLET;ORAL	Prescription	No	AB	214816	MSN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	214816	MSN
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	077555	SUN PHARM INDS

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