Last Updated: August 3, 2026

Details for New Drug Application (NDA): 071591

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NDA 071591 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 071591

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

Pharmacology for NDA: 071591

Medical Subject Heading (MeSH) Categories for 071591

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 071591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	TABLET;ORAL	071591	ANDA	Chartwell RX, LLC	62135-861	62135-861-01	100 TABLET in 1 BOTTLE (62135-861-01)
LORAZEPAM	lorazepam	TABLET;ORAL	071591	ANDA	Chartwell RX, LLC	62135-862	62135-862-01	100 TABLET in 1 BOTTLE (62135-862-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 13, 1987	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 13, 1987	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 13, 1987	TE:		RLD:	No

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