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Details for 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 five 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. Five suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for NDA: 020646

tiagabine hydrochloride
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 020646

Suppliers and Packaging for NDA: 020646

Tradename Generic Name Dosage NDA Supplier National Drug Code Package Code Package
tiagabine hydrochloride
TABLET;ORAL 020646 STAT RX USA LLC 16590-832 16590-832-30 30 TABLET in 1 BOTTLE (16590-832-30)
tiagabine hydrochloride
TABLET;ORAL 020646 STAT RX USA LLC 16590-832 16590-832-45 45 TABLET in 1 BOTTLE (16590-832-45)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET; ORALStrength4MG
Approval Date:Sep 30, 1997TE:RLD:Yes
Patent:5,010,090Patent Expiration:Sep 30, 2011Product Flag?Substance Flag?Delist Request?
Patent:5,354,760Patent Expiration:Mar 24, 2012Product Flag?Substance Flag?Delist Request?
Patent:5,866,590Patent Expiration:Apr 29, 2016Product Flag?Substance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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