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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 217598

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NDA 217598 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 217598

Tradename:	LORAZEPAM
Applicant:	Fresenius Kabi Usa
Ingredient:	lorazepam
Patents:	0

Pharmacology for NDA: 217598

Medical Subject Heading (MeSH) Categories for 217598

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 217598

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORAZEPAM	lorazepam	INJECTABLE;INJECTION	217598	ANDA	Fresenius Kabi USA, LLC	65219-368	65219-368-02	25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Nov 18, 2024	TE:	AP	RLD:	No

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