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. It is available from two suppliers. Additional details are available on the GABITRIL profile page.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are six drug master file entries for this compound. Six 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020646

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 020646

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5030	0093-5030-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)
GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5031	0093-5031-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)

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

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