Last Updated: September 24, 2026

Details for New Drug Application (NDA): 016087

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NDA 016087 describes VALIUM, which is a drug marketed by Roche and Waylis Therap and is included in two NDAs. It is available from two suppliers. Additional details are available on the VALIUM profile page.

The generic ingredient in VALIUM is diazepam. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 016087

Tradename:	VALIUM
Applicant:	Roche
Ingredient:	diazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 016087

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016087

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	VALIUM	diazepam	INJECTABLE;INJECTION	016087-001	Approved Prior to Jan 1, 1982	4,316,897	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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