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 one Paragraph IV challenge. 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.
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET; ORAL||Strength||4MG|
|Approval Date:||Sep 30, 1997||TE:||RLD:||Yes|
|Patent:||5,010,090||Patent Expiration:||Sep 30, 2011||Product Flag?||Substance Flag?||Delist Request?|
|Patent:||5,354,760||Patent Expiration:||Mar 24, 2012||Product Flag?||Substance Flag?||Delist Request?|
|Patent:||5,866,590||Patent Expiration:||Apr 29, 2016||Product Flag?||Substance Flag?||Delist Request?|
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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