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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020648

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NDA 020648 describes DIASTAT ACUDIAL, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from three suppliers. Additional details are available on the DIASTAT ACUDIAL profile page.

The generic ingredient in DIASTAT ACUDIAL is diazepam. There are eight drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 020648
Tradename:DIASTAT ACUDIAL
Applicant:Valeant Pharms North
Ingredient:diazepam
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIASTAT diazepam GEL;RECTAL 020648 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-6137 0093-6137-32 2 SYRINGE, PLASTIC in 1 PACKAGE (0093-6137-32) > .5 mL in 1 SYRINGE, PLASTIC
DIASTAT diazepam GEL;RECTAL 020648 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-6138 0093-6138-32 2 SYRINGE, PLASTIC in 1 PACKAGE (0093-6138-32) > 2 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;RECTALStrength2.5MG/0.5ML (5MG/ML)
Approval Date:Jul 29, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GEL;RECTALStrength5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 29, 1997TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:GEL;RECTALStrength10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 29, 1997TE:RLD:Yes

Expired US Patents for NDA 020648

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-006 Sep 15, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT diazepam GEL;RECTAL 020648-001 Jul 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT diazepam GEL;RECTAL 020648-004 Jul 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT ACUDIAL diazepam GEL;RECTAL 020648-007 Sep 15, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT diazepam GEL;RECTAL 020648-003 Jul 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT diazepam GEL;RECTAL 020648-002 Jul 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North DIASTAT diazepam GEL;RECTAL 020648-005 Jul 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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