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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 six suppliers. There are two patents protecting this drug and two Paragraph IV challenges. 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. Seven suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for NDA: 020646

Tradename:
GABITRIL
Applicant:
Cephalon
Ingredient:
tiagabine hydrochloride
Patents:2
Therapeutic Class:Anticonvulsants
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:5,866,590Patent Expiration:Apr 29, 2016Product Flag?Substance Flag?Delist Request?
Patent:5,958,951Patent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12MG
Approval Date:Sep 30, 1997TE:RLD:No
Patent:5,866,590Patent Expiration:Apr 29, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020646

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-004Sep 30, 19975,866,590► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-002Sep 30, 19975,866,590► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-004Sep 30, 19975,010,090► subscribe
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