Last Updated: August 15, 2026

Details for New Drug Application (NDA): 090260

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NDA 090260 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 090260

Tradename:	LORAZEPAM
Applicant:	Pharm Assoc
Ingredient:	lorazepam
Patents:	0

Pharmacology for NDA: 090260

Medical Subject Heading (MeSH) Categories for 090260

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 090260

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	CONCENTRATE;ORAL	090260	ANDA	Pharmaceutical Associates, Inc.	0121-0770	0121-0770-01	1 BOTTLE, DROPPER in 1 CARTON (0121-0770-01) / 30 mL in 1 BOTTLE, DROPPER
LORAZEPAM	lorazepam	CONCENTRATE;ORAL	090260	ANDA	American Health Packaging	68000-107	68000-107-05	50 SYRINGE in 1 CARTON (68000-107-05) / .25 mL in 1 SYRINGE (68000-107-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	2MG/ML
Approval Date:	Jun 15, 2010	TE:	AA	RLD:	No

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