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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 211998

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NDA 211998 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-three 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-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 211998

Tradename:	DIAZEPAM
Applicant:	Regcon Holdings
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 211998

Medical Subject Heading (MeSH) Categories for 211998

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

Suppliers and Packaging for NDA: 211998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	INJECTABLE;INJECTION	211998	ANDA	Natco Pharma USA LLC	69339-137	69339-137-05	5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05) / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)
DIAZEPAM	diazepam	INJECTABLE;INJECTION	211998	ANDA	Medical Purchasing Solutions, LLC	71872-7259	71872-7259-1	1 VIAL, MULTI-DOSE in 1 BAG (71872-7259-1) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/10ML (5MG/ML)
Approval Date:	Dec 26, 2019	TE:	AP	RLD:	No

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