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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 NDA: 018976

Tradename:
LEVATOL
Applicant:
Auxilium Pharms Llc
Ingredient:
penbutolol sulfate
Patents:0
Therapeutic Class:Cardiovascular Agents

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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