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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 020539

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NDA 020539 describes LAMISIL, which is a drug marketed by Karo Hlthcare and Novartis and is included in eight NDAs. It is available from two suppliers. Additional details are available on the LAMISIL profile page.

The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. Additional details are available on the terbinafine profile page.
Summary for 020539
Ingredient:terbinafine hydrochloride
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 10, 1996TE:RLD:Yes

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