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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 072927

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NDA 072927 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 072927

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

Pharmacology for NDA: 072927

Medical Subject Heading (MeSH) Categories for 072927

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 072927

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	TABLET;ORAL	072927	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3426	0093-3426-01	100 TABLET in 1 BOTTLE, PLASTIC (0093-3426-01)
LORAZEPAM	lorazepam	TABLET;ORAL	072927	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3426	0093-3426-05	500 TABLET in 1 BOTTLE, PLASTIC (0093-3426-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 31, 1991	TE:	AB	RLD:	No

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