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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 013263

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NDA 013263 describes VALIUM, which is a drug marketed by Roche and is included in two NDAs. It is available from one supplier. Additional details are available on the VALIUM profile page.

The generic ingredient in VALIUM is diazepam. There are eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 013263
Tradename:VALIUM
Applicant:Roche
Ingredient:diazepam
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 013263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALIUM diazepam TABLET;ORAL 013263 NDA Roche Laboratories Inc. 0140-0004 0140-0004-01 1 BOTTLE, PLASTIC in 1 CARTON (0140-0004-01) > 100 TABLET in 1 BOTTLE, PLASTIC
VALIUM diazepam TABLET;ORAL 013263 NDA Roche Laboratories Inc. 0140-0005 0140-0005-01 1 BOTTLE, PLASTIC in 1 CARTON (0140-0005-01) > 100 TABLET in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 013263
Tradename Dosage Ingredient NDA Submissiondate
VALIUM TABLET;ORAL diazepam 013263

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 013263

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche VALIUM diazepam TABLET;ORAL 013263-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Roche VALIUM diazepam TABLET;ORAL 013263-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Roche VALIUM diazepam TABLET;ORAL 013263-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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