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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020315

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NDA 020315 describes ORLAAM, which is a drug marketed by Roxane and is included in one NDA. Additional details are available on the ORLAAM profile page.

The generic ingredient in ORLAAM is levomethadyl acetate hydrochloride. There is one drug master file entry for this compound. Additional details are available on the levomethadyl acetate hydrochloride profile page.
Summary for 020315
Tradename:ORLAAM
Applicant:Roxane
Ingredient:levomethadyl acetate hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CONCENTRATE;ORALStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 9, 1993TE:RLD:Yes

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