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Details for Generic Name: tolcapone

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Tolcapone is the generic ingredient in two branded drugs marketed by Valeant Pharms Llc and Par Pharm Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tolcapone. One supplier is listed for this compound.

Summary for Generic Name: tolcapone

Drug Master File Entries: see list4
Suppliers / Packaging: see list2
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tolcapone

Clinical Trials for: tolcapone

Tolcapone Treatment of Pathological Gambling
Status: Completed Condition: Pathological Gambling

Pilot Study of Tolcapone in Smokers
Status: Completed Condition: Nicotine Dependence

Clinical Trial of Tolcapone for Cognition in Schizophrenia
Status: Recruiting Condition: Schizophrenia

Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance
Status: Completed Condition: Healthy

Effects of Tolcapone on Frontotemporal Dementia
Status: Completed Condition: Frontotemporal Lobar Degeneration

Treatment for Nicotine Addiction in Women
Status: Not yet recruiting Condition: Nicotine Dependence

A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors
Status: Recruiting Condition: Impulsive Behavior

Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
Status: Active, not recruiting Condition: Cocaine-Related Disorders

Neural Substrates in Nicotine Withdrawal
Status: Completed Condition: Tobacco Use Disorder

Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
Status: Completed Condition: Parkinson Disease

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Llc
TABLET;ORAL020697-002Jan 29, 1998DISCNNo<disabled><disabled>
Par Pharm Inc
TABLET;ORAL204584-001Mar 26, 2015RXNo<disabled><disabled>
Valeant Pharms Llc
TABLET;ORAL020697-001Jan 29, 1998RXYes<disabled><disabled>
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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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