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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020261


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NDA 020261 describes LESCOL, which is a drug marketed by Novartis and Sandoz and is included in two NDAs. Additional details are available on the LESCOL profile page.

The generic ingredient in LESCOL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 020261
Tradename:LESCOL
Applicant:Novartis
Ingredient:fluvastatin sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 31, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 31, 1993TE:RLD:Yes

Expired US Patents for NDA 020261

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ⤷  Try a Trial ⤷  Try a Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ⤷  Try a Trial ⤷  Try a Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ⤷  Try a Trial ⤷  Try a Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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