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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018976

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NDA 018976 describes LEVATOL, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. Additional details are available on the LEVATOL profile page.

The generic ingredient in LEVATOL is penbutolol sulfate. There are two drug master file entries for this compound. Additional details are available on the penbutolol sulfate profile page.
Summary for 018976
Tradename:LEVATOL
Applicant:Auxilium Pharms Llc
Ingredient:penbutolol sulfate
Patents:0
Therapeutic Class:Cardiovascular Agents
Medical Subject Heading (MeSH) Categories for 018976

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1987TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 5, 1989TE:RLD:Yes

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