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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 070200

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NDA 070200 describes LORAZ, which is a drug marketed by Quantum Pharmics, Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, 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-nine NDAs. Additional details are available on the LORAZ profile page.

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

Summary for 070200

Tradename:	LORAZ
Applicant:	Quantum Pharmics
Ingredient:	lorazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 070200

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 9, 1985	TE:		RLD:	No

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