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, Dr Reddys, Endo Operations, Epic Pharma Llc, Hospira, Intl Medication Sys, Rising, Watson Labs, Roxane, Am Therap, Anda Repository, Ani Pharms, Aurolife Pharma Llc, Chartwell Rx, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Warner Chilcott, and Bedford Labs, and is included in sixty-four NDAs. It is available from thirty-three 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-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

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

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

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

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

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