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Last Updated: April 22, 2021

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Details for New Drug Application (NDA): 072555

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NDA 072555 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Hi-tech Pharma Co, Lannett Co Inc, Lupin Ltd, Pharm Assoc, Akorn, Bedford, Dava Pharms Inc, Dr Reddys, Hospira, Intl Medication Sys, Mylan Asi, Watson Labs, West-ward Pharms Int, Roxane, Am Therap, Anda Repository, Ani Pharms Inc, Aurolife Pharma Llc, Halsey, Leading Pharma Llc, Mutual Pharm, Mylan, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Warner Chilcott, Hikma, 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-six suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 072555
Tradename:LORAZEPAM
Applicant:Anda Repository
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 072555

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Mar 29, 1991TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 29, 1991TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Mar 29, 1991TE:RLD:No

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