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Last Updated: January 2, 2025

Details for New Drug Application (NDA): 070464

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NDA 070464 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, and Virtus, and is included in seventy-eight NDAs. It is available from forty-two suppliers. Additional details are available on the DIAZEPAM profile page.

The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 070464

Tradename:	DIAZEPAM
Applicant:	Nuvo Pharm
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 070464

Medical Subject Heading (MeSH) Categories for 070464

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

Suppliers and Packaging for NDA: 070464

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	TABLET;ORAL	070464	ANDA	Sunrise Pharmaceutical, Inc.	11534-199	11534-199-01	100 TABLET in 1 BOTTLE (11534-199-01)
DIAZEPAM	diazepam	TABLET;ORAL	070464	ANDA	Sunrise Pharmaceutical, Inc.	11534-199	11534-199-03	1000 TABLET in 1 BOTTLE (11534-199-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 25, 1986	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Sep 10, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 10, 2024	TE:	AB	RLD:	No

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