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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 217468

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NDA 217468 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 217468

Tradename:	DIAZEPAM
Applicant:	Navinta Llc
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 217468

Medical Subject Heading (MeSH) Categories for 217468

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

Suppliers and Packaging for NDA: 217468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	GEL;RECTAL	217468	ANDA	Navinta LLC	68475-802	68475-802-02	2 SYRINGE, PLASTIC in 1 PACKAGE (68475-802-02) / .5 mL in 1 SYRINGE, PLASTIC
DIAZEPAM	diazepam	GEL;RECTAL	217468	ANDA	Navinta LLC	68475-803	68475-803-02	2 SYRINGE, PLASTIC in 1 PACKAGE (68475-803-02) / 2 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	2.5MG/0.5ML (5MG/ML)
Approval Date:	Nov 14, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	10MG/2ML (5MG/ML)
Approval Date:	Nov 14, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	20MG/4ML (5MG/ML)
Approval Date:	Nov 14, 2025	TE:	AB	RLD:	No

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