Last Updated: September 28, 2026

Details for New Drug Application (NDA): 020648

✉ Email this page to a colleague

NDA 020648 describes DIASTAT ACUDIAL, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the DIASTAT ACUDIAL profile page.

The generic ingredient in DIASTAT ACUDIAL 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 020648

Tradename:	DIASTAT ACUDIAL
Applicant:	Bausch
Ingredient:	diazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 020648

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

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	Oceanside Pharmaceuticals	68682-650	68682-650-20	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-650-20) / .5 mL in 1 SYRINGE, PLASTIC
DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-650	68682-650-20	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-650-20) / .5 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	2.5MG/0.5ML (5MG/ML)
Approval Date:	Jul 29, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;RECTAL			Strength	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 29, 1997	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;RECTAL			Strength	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 29, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020648

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997	5,462,740	⤷ Start Trial
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-001	Jul 29, 1997	5,462,740	⤷ Start Trial
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997	5,462,740	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.