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Profile for Tradename: DIASTAT

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Diastat is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from two suppliers.

The generic ingredient in DIASTAT is diazepam. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for Tradename: DIASTAT

Suppliers / Packagers: see list6

Pharmacology for Tradename: DIASTAT

Drug ClassBenzodiazepine

Clinical Trials for: DIASTAT

Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems
Status: Terminated Condition: Metabolism, Drug

A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Status: Completed Condition: Epilepsy

A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Status: Recruiting Condition: Refractory Epilepsy

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Status: Completed Condition: Seizures

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Status: Active, not recruiting Condition: Posttraumatic Stress Disorder

Freedom SOLO Stentless Heart Valve Study
Status: Completed Condition: Aortic Stenosis; Aortic Insufficiency

Exploring the Effects of Diazepam and Lorazepam
Status: Completed Condition: Healthy Subjects

Vaginal Diazepam for the Treatment of Female Pelvic Pain
Status: Recruiting Condition: Pelvic Floor Disorders; Pelvic Pain

A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
Status: Completed Condition: Alcohol Withdrawal

Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Status: Recruiting Condition: Alcoholism

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 North
GEL;RECTAL020648-001Jul 29, 1997RXNo<disabled><disabled>
Valeant Pharms North
GEL;RECTAL020648-006Sep 15, 2005RXYes<disabled><disabled>
Valeant Pharms North
GEL;RECTAL020648-004Jul 29, 1997DISCNNo<disabled><disabled>
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Paragraph IV activity for: DIASTAT

Drugname Dosage Strength RLD Submissiondate
diazepamRectal Gel5 mg/mL, 2mL pre-filled syringeDiastat Acudial12/23/2008
diazepamRectal Gel5 mg/mL, 4mL pre-filled syringeDiastat Acudial12/8/2008
diazepamRectal Gel2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mLDiastat3/23/2004
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Preferred citation:

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

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