Details for New Drug Application (NDA): 074243

NDA 074243 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 074243

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

Pharmacology for NDA: 074243

Medical Subject Heading (MeSH) Categories for 074243

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Suppliers and Packaging for NDA: 074243

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074243	ANDA	Hospira, Inc.	0409-1985	0409-1985-30	10 CARTRIDGE in 1 CARTON (0409-1985-30) / 1 mL in 1 CARTRIDGE (0409-1985-03)
LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074243	ANDA	REMEDYREPACK INC.	70518-3766	70518-3766-0	10 CARTRIDGE in 1 CARTON (70518-3766-0) / 1 mL in 1 CARTRIDGE (70518-3766-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 12, 1994	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MG/ML
Approval Date:	Apr 12, 1994	TE:	AP	RLD:	No

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