CardiovascularORALGeneric

LESCOL

FLUVASTATIN SODIUM

Standard Dose

EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: 901 REQUIRED Marketing status: Discontinued

Summary

Approval overview LESCOL is listed in Drugs@FDA under application 020261 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient FLUVASTATIN SODIUM Form and strength CAPSULE;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor NOVARTIS Submission history Latest submission status date: 2017-08-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview LESCOL is listed in Drugs@FDA under application 020261 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient FLUVASTATIN SODIUM Form and strength CAPSULE;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor NOVARTIS Submission history Latest submission status date: 2017-08-04 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: 901 REQUIRED

Interaction Notes

No interaction notes stored yet.