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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020648

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

The generic ingredient in DIASTAT ACUDIAL is diazepam. There are eight drug master file entries for this compound. Forty-two 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020648

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	Bausch Health US, LLC	0187-0658	0187-0658-20	2 SYRINGE, PLASTIC in 1 PACKAGE (0187-0658-20) / 2 mL in 1 SYRINGE, PLASTIC
DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648	NDA	Bausch Health US, LLC	0187-0658	0187-0658-20	2 SYRINGE, PLASTIC in 1 PACKAGE (0187-0658-20) / 2 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:		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DISCN	Dosage:	GEL;RECTAL			Strength	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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Dosage:	GEL;RECTAL			Strength	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-003	Jul 29, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-001	Jul 29, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005	⤷ Try a Trial	⤷ Try a Trial
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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