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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 091076

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NDA 091076 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, and Virtus, and is included in seventy-eight 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-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 091076

Tradename:	DIAZEPAM
Applicant:	Novel Labs Inc
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 091076

Medical Subject Heading (MeSH) Categories for 091076

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

Suppliers and Packaging for NDA: 091076

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	GEL;RECTAL	091076	ANDA	Lupin Pharmaceuticals,Inc.	43386-280	43386-280-02	1 PACKAGE in 1 CARTON (43386-280-02) / 2 SYRINGE in 1 PACKAGE (43386-280-01) / 2 g in 1 SYRINGE (43386-280-03)
DIAZEPAM	diazepam	GEL;RECTAL	091076	ANDA	Lupin Pharmaceuticals,Inc.	43386-281	43386-281-02	1 PACKAGE in 1 CARTON (43386-281-02) / 2 SYRINGE in 1 PACKAGE (43386-281-01) / 4 g in 1 SYRINGE (43386-281-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	10MG/2ML (5MG/ML)
Approval Date:	May 30, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;RECTAL			Strength	20MG/4ML (5MG/ML)
Approval Date:	May 30, 2023	TE:	AB	RLD:	No

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