Lescol Xl

NDA 21192, held by Sandoz. Fluvastatin Sodium.

First approved: Oct 6, 2000
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Apr 10, 2006	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 10, 2006	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 27, 2003	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 6, 2000	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lescol XlEQ 80MG BASE · tablet, extended release;oral	Fluvastatin Sodium	Rx · reference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 28, 2023	Supplement 29Labeling · Standard review	Approved	Label Letter
Sep 25, 2020	Supplement 31Labeling	Approved	Label Letter
Aug 4, 2017	Supplement 26Labeling	Approved	Label Letter
Nov 5, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 25, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 31, 2012	Supplement 21Labeling	Approved	Label Letter
Feb 28, 2012	Supplement 19Labeling	Approved	Review Letter Label Other
Jun 17, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 12, 2007	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 10, 2006	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 10, 2006	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 22, 2006	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 5, 2005	Supplement 8Labeling · Standard review	Approved	Label Letter
May 27, 2003	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 6, 2002	Supplement 4Labeling · Standard review	Approved	Review Letter Label
Feb 11, 2002	Supplement 3Manufacturing · Standard review	Approved	Review
Sep 25, 2001	Supplement 2Labeling · Standard review	Approved	Label
Sep 24, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 6, 2000	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 21192
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters