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Generated: October 21, 2018

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Details for New Drug Application (NDA): 077396

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NDA 077396 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Anda Repository, Hi-tech Pharma Co, Lupin Ltd, Pharm Assoc, Akorn, Bedford, Dava Pharms Inc, Hospira, Intl Medication Sys, Mylan Asi, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Roxane, Am Therap, 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, and Bedford Labs, and is included in sixty-four NDAs. It is available from fifty-two 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-four suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 077396
Tradename:LORAZEPAM
Applicant:Ani Pharms Inc
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077396

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 13, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 13, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 13, 2006TE:ABRLD:No

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