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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 074551

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NDA 074551 describes LORAZEPAM, which is a drug marketed by 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-six NDAs. It is available from thirty-four 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for 074551

Tradename:	LORAZEPAM
Applicant:	Pharmobedient
Ingredient:	lorazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 074551

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Sep 12, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4MG/ML
Approval Date:	Sep 12, 1996	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Sep 12, 1996	TE:		RLD:	No

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