Last Updated: November 8, 2026

Details for New Drug Application (NDA): 020646

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NDA 020646 describes GABITRIL, which is a drug marketed by Cephalon and is included in one NDA. Additional details are available on the GABITRIL profile page.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for 020646

Tradename:	GABITRIL
Applicant:	Cephalon
Ingredient:	tiagabine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	16MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020646

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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