Last Updated: August 8, 2026

Details for New Drug Application (NDA): 079244

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NDA 079244 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Caplin, Epic Pharma Llc, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Ph Health, Pharmobedient, Rising, Watson Labs, Roxane, Am Therap, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Tp Anda Holdings, Usl Pharma, Warner Chilcott, and Bedford Labs, and is included in sixty-six NDAs. It is available from thirty-six suppliers. Additional details are available on the LORAZEPAM profile page.

The generic ingredient in LORAZEPAM is lorazepam. There are eleven drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for 079244

Tradename:	LORAZEPAM
Applicant:	Chartwell Molecular
Ingredient:	lorazepam
Patents:	0

Pharmacology for NDA: 079244

Medical Subject Heading (MeSH) Categories for 079244

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 079244

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	CONCENTRATE;ORAL	079244	ANDA	Chartwell RX, LLC	62135-549	62135-549-43	30 mL in 1 BOTTLE (62135-549-43)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CONCENTRATE;ORAL			Strength	2MG/ML
Approval Date:	Apr 28, 2009	TE:		RLD:	No

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