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Last Updated: January 21, 2020

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Details for New Drug Application (NDA): 019507

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NDA 019507 describes KERLONE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the KERLONE profile page.

The generic ingredient in KERLONE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 019507
Tradename:KERLONE
Applicant:Sanofi Aventis Us
Ingredient:betaxolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019507

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Oct 27, 1989TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 27, 1989TE:RLD:No

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