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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 206477

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NDA 206477 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 206477

Tradename:	DIAZEPAM
Applicant:	Chartwell Molecular
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 206477

Medical Subject Heading (MeSH) Categories for 206477

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

Suppliers and Packaging for NDA: 206477

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	SOLUTION;ORAL	206477	ANDA	Chartwell RX, LLC	62135-767	62135-767-24	2 TRAY in 1 BOX (62135-767-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-767-45)
DIAZEPAM	diazepam	SOLUTION;ORAL	206477	ANDA	Chartwell RX, LLC	62135-767	62135-767-47	473 mL in 1 BOTTLE (62135-767-47)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jun 24, 2016	TE:	AA	RLD:	No

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