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Generated: August 21, 2018

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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 three suppliers. Additional details are available on the GABITRIL profile page.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are five 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
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 N 0093-5030-56
GABITRIL tiagabine hydrochloride TABLET;ORAL 020646 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-5031 N 0093-5031-56

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

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