Last Updated: August 8, 2026

Details for New Drug Application (NDA): 078203

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NDA 078203 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 078203

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

Pharmacology for NDA: 078203

Medical Subject Heading (MeSH) Categories for 078203

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 078203

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	TABLET;ORAL	078203	ANDA	Major Pharmaceuticals	0904-6007	0904-6007-61	100 BLISTER PACK in 1 CARTON (0904-6007-61) / 1 TABLET in 1 BLISTER PACK
LORAZEPAM	lorazepam	TABLET;ORAL	078203	ANDA	Major Pharmaceuticals	0904-6008	0904-6008-60	100 TABLET in 1 BOTTLE (0904-6008-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Jul 30, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 30, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jul 30, 2007	TE:	AB	RLD:	No

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