Last Updated: September 24, 2026

Details for New Drug Application (NDA): 070928

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NDA 070928 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Navinta Llc, Novel Labs Inc, Abraxis Pharm, Alembic, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Galenicum Hlth, Hikma, Hospira, Long Grove Pharms, Lupin, 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-three NDAs. It is available from forty-six suppliers. Additional details are available on the DIAZEPAM profile page.

The generic ingredient in DIAZEPAM is diazepam. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 070928

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

Pharmacology for NDA: 070928

Medical Subject Heading (MeSH) Categories for 070928

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

Suppliers and Packaging for NDA: 070928

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	SOLUTION;ORAL	070928	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3188	0054-3188-63	500 mL in 1 BOTTLE, PLASTIC (0054-3188-63)
DIAZEPAM	diazepam	SOLUTION;ORAL	070928	ANDA	Pharmaceutical Associates, Inc.	0121-0905	0121-0905-94	3 TRAY in 1 CASE (0121-0905-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Apr 3, 1987	TE:	AA	RLD:	No

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