Last Updated: November 8, 2026

Details for New Drug Application (NDA): 071118

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NDA 071118 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-five suppliers. Additional details are available on the LORAZEPAM profile page.

The generic ingredient in LORAZEPAM is lorazepam. There is one drug master file entry for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for 071118

Tradename:	LORAZEPAM
Applicant:	Watson Labs
Ingredient:	lorazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 071118

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 24, 1986	TE:		RLD:	No

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