← FDA DRUG APPROVALS

FDA NDA · NDA020261

LESCOL

Sponsor: NOVARTIS

APPLICATION
NDA020261
TYPE
NDA
ORIGINAL APPROVAL
1993-12-31
LATEST ACTION
2017-08-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LESCOL · ReferenceDiscontinued
FLUVASTATIN SODIUM EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LESCOL · ReferenceDiscontinued
FLUVASTATIN SODIUM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2017-08-04Labeling · Supplement 52 · 901 requiredLabelAP
2015-11-05Manufacturing (CMC) · Supplement 50 · standardAP
2015-06-17Manufacturing (CMC) · Supplement 49 · standardAP
2013-06-25Manufacturing (CMC) · Supplement 47 · standardAP
2012-10-31Labeling · Supplement 48 · 901 requiredLetterAP
2012-02-28Labeling · Supplement 46 · unknownReviewAP
2011-06-17Labeling · Supplement 42 · standardLetterAP
2007-06-12Labeling · Supplement 39 · standardLabelAP
2006-04-10Efficacy · Supplement 35 · unknownLetterAP
2006-04-10Efficacy · Supplement 36 · priorityPediatric Medical ReviewAP
2006-03-22Labeling · Supplement 37 · standardLabelAP
2005-01-05Labeling · Supplement 34 · standardReviewAP
2003-05-27Efficacy · Supplement 33 · standardReviewAP
2002-09-06Labeling · Supplement 32 · standardLabelAP
2002-02-11Manufacturing (CMC) · Supplement 31 · standardReviewAP
2001-09-25Labeling · Supplement 30 · standardLabelAP
2001-05-23Manufacturing (CMC) · Supplement 29 · standardReviewAP
2000-12-18Efficacy · Supplement 25 · standardLetterAP
2000-10-23Efficacy · Supplement 24 · standardLetterAP
2000-10-06Labeling · Supplement 28 · standardLabelAP
2000-07-26Manufacturing (CMC) · Supplement 27 · standardAP
1999-10-14Manufacturing (CMC) · Supplement 23 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 21 · standardReviewAP
1999-04-21Manufacturing (CMC) · Supplement 20 · standardReviewAP
1999-03-08Efficacy · Supplement 18 · standardReviewAP
1999-03-08Efficacy · Supplement 22 · standardReviewAP
1999-01-04Labeling · Supplement 19 · standardReviewAP
1998-10-08Manufacturing (CMC) · Supplement 11 · standardReviewAP
1998-08-05Manufacturing (CMC) · Supplement 17 · standardReviewAP
1998-04-23Manufacturing (CMC) · Supplement 16 · standardReviewAP
1997-11-20Manufacturing (CMC) · Supplement 15 · standardReviewAP
1997-10-01Efficacy · Supplement 12 · standardAP
1997-06-16Manufacturing (CMC) · Supplement 13 · standardReviewAP
1997-04-21Manufacturing (CMC) · Supplement 14 · standardReviewAP
1996-04-30Manufacturing (CMC) · Supplement 10 · standardReviewAP
1996-03-20Efficacy · Supplement 6 · standardAP
1996-02-08Manufacturing (CMC) · Supplement 9 · standardReviewAP
1995-12-22Manufacturing (CMC) · Supplement 8 · standardAP
1995-10-17Manufacturing (CMC) · Supplement 7 · standardReviewAP
1995-05-03Labeling · Supplement 5 · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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