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DIASTAT Drug Profile

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

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

Summary for Tradename: DIASTAT

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: DIASTAT

Ingredient-typeBenzodiazepines
Drug ClassBenzodiazepine

Clinical Trials for: DIASTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-001Jul 29, 1997RXNo<disabled><disabled>
Valeant Pharms North
DIASTAT ACUDIAL
diazepam
GEL;RECTAL020648-006Sep 15, 2005RXYes<disabled><disabled>
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-004Jul 29, 1997DISCNNo<disabled><disabled>
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Expired Patents for Tradename: DIASTAT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-001Jul 29, 19975,462,740<disabled>
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-005Jul 29, 19975,462,740<disabled>
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-003Jul 29, 19975,462,740<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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