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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 200542

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NDA 200542 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 200542

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

Medical Subject Heading (MeSH) Categories for 200542

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 28, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4MG/ML
Approval Date:	Apr 28, 2017	TE:		RLD:	No

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