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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 218450

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NDA 218450 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 218450

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

Pharmacology for NDA: 218450

Medical Subject Heading (MeSH) Categories for 218450

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

Suppliers and Packaging for NDA: 218450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	INJECTABLE;INJECTION	218450	ANDA	Alembic Pharmaceuticals Limited	46708-811	46708-811-20	10 SYRINGE, GLASS in 1 CARTON (46708-811-20) / 2 mL in 1 SYRINGE, GLASS (46708-811-02)
DIAZEPAM	diazepam	INJECTABLE;INJECTION	218450	ANDA	Alembic Pharmaceuticals Inc.	62332-811	62332-811-20	10 SYRINGE, GLASS in 1 CARTON (62332-811-20) / 2 mL in 1 SYRINGE, GLASS (62332-811-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/2ML (5MG/ML)
Approval Date:	Apr 25, 2024	TE:	AP	RLD:	No

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