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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 091407

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NDA 091407 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.

Summary for 091407

Tradename:	LORAZEPAM
Applicant:	Lupin Ltd
Ingredient:	lorazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 091407

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	2MG/ML
Approval Date:	Feb 19, 2013	TE:	AA	RLD:	No

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