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Last Updated: June 24, 2021

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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. Four 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
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)
Paragraph IV (Patent) Challenges for 020646
Tradename Dosage Ingredient NDA Submissiondate
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2014-01-24
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2005-02-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020646

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-005 Apr 16, 1999   Try Before You Buy   Try Before You Buy
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997   Try Before You Buy   Try Before You Buy
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-001 Sep 30, 1997   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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