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Details for New Drug Application (NDA): 018179

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NDA 018179 describes VALRELEASE, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the VALRELEASE profile page.

The generic ingredient in VALRELEASE 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: 018179

Tradename:
VALRELEASE
Applicant:
Roche
Ingredient:
diazepam
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018179

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
VALRELEASE
diazepam
CAPSULE, EXTENDED RELEASE;ORAL018179-001Approved Prior to Jan 1, 19824,316,897► subscribe
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