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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 013263

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NDA 013263 describes VALIUM, which is a drug marketed by Roche and Waylis Therap 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-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 013263

Tradename:	VALIUM
Applicant:	Waylis Therap
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 013263

Medical Subject Heading (MeSH) Categories for 013263

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

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 013263

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-002	Approved Prior to Jan 1, 1982	4,316,897	⤷ Get Started Free
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-006	Approved Prior to Jan 1, 1982	4,316,897	⤷ Get Started Free
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982	4,316,897	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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