Last Updated: May 10, 2026

Details for New Drug Application (NDA): 070312

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NDA 070312 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Navinta Llc, Novel Labs Inc, Abraxis Pharm, Alembic, Dr Reddys, Fresenius Kabi Usa, Galenicum Hlth, Hikma, Hospira, Long Grove Pharms, Marsam Pharms Llc, Parenta Pharms, Regcon Holdings, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Ph Health, Pioneer Pharms, Roxane, Strides Pharma Intl, Teva Pharms, and Virtus, and is included in eighty-one NDAs. It is available from forty-four 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 070312

Tradename:	DIAZEPAM
Applicant:	Hikma
Ingredient:	diazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 070312

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
Approval Date:	Dec 16, 1985	TE:		RLD:	No

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