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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 two 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. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for NDA: 020648

Tradename:
DIASTAT
Applicant:
Valeant Pharms North
Ingredient:
diazepam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020648

Ingredient-typeBenzodiazepines

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;RECTALStrength2.5MG/0.5ML (5MG/ML)
Approval Date:Jul 29, 1997TE:RLD:No

Summary 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(5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:GEL;RECTALStrength10MG/2ML (5MG/ML)
Approval Date:Jul 29, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020648

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
DIASTAT ACUDIAL
diazepam
GEL;RECTAL020648-006Sep 15, 20055,462,740► subscribe
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-001Jul 29, 19975,462,740► subscribe
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-004Jul 29, 19975,462,740► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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