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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074300

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NDA 074300 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Hi-tech Pharma Co, Lupin Ltd, Pharm Assoc, Saptalis Pharms, Akorn, Bedford, Dava Pharms Inc, Hospira, Intl Medication Sys, Mylan Asi, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Roxane, Am Therap, Anda Repository, Ani Pharms Inc, Aurolife Pharma Llc, Halsey, Leading Pharma Llc, Mutual Pharm, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Vintage Pharms, Warner Chilcott, and Bedford Labs, and is included in sixty-six NDAs. It is available from fifty-one 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. Fifty-three suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 074300
Tradename:LORAZEPAM
Applicant:Hospira
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074300
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 074300
Suppliers and Packaging for NDA: 074300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORAZEPAM lorazepam INJECTABLE;INJECTION 074300 ANDA Physicians Total Care, Inc. 54868-3566 E 54868-3566-2
LORAZEPAM lorazepam INJECTABLE;INJECTION 074300 ANDA Physicians Total Care, Inc. 54868-3566 E 54868-3566-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Apr 12, 1994TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4MG/ML
Approval Date:Mar 19, 1997TE:RLD:No

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