Last Updated: May 10, 2026

Details for New Drug Application (NDA): 070325

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NDA 070325 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 070325

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

Pharmacology for NDA: 070325

Medical Subject Heading (MeSH) Categories for 070325

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

Suppliers and Packaging for NDA: 070325

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	TABLET;ORAL	070325	ANDA	Mylan Pharmaceuticals Inc.	0378-0271	0378-0271-01	100 TABLET in 1 BOTTLE, PLASTIC (0378-0271-01)
DIAZEPAM	diazepam	TABLET;ORAL	070325	ANDA	Mylan Pharmaceuticals Inc.	0378-0271	0378-0271-05	500 TABLET in 1 BOTTLE, PLASTIC (0378-0271-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 4, 1985	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Sep 4, 1985	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 4, 1985	TE:	AB	RLD:	No

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