Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020261
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LESCOL FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE;ORAL Discontinued None Yes No
LESCOL FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2017 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020261s052,021192s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020261Orig1s052,021192Orig1s026ltr.pdf
11/05/2015 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/17/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/31/2012 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf
06/25/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/28/2012 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020261s046.pdf
06/17/2011 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf
06/12/2007 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf
03/22/2006 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf
04/10/2006 SUPPL-36 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf
04/10/2006 SUPPL-35 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf
01/05/2005 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020261_s034_Lescol Capsules.pdf
05/27/2003 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020261_S033_LESCOL_CAPS_AP.pdf
09/06/2002 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s032_LESCOL_CAPSULES.pdf
02/11/2002 SUPPL-31 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s031_LESCOL_CAPSULES.pdf
09/25/2001 SUPPL-30 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20261s30lbl.pdf
05/23/2001 SUPPL-29 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020261_s029_LESCOL_CAPSULES.pdf
10/06/2000 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm
07/26/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/18/2000 SUPPL-25 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S25ltr.pdf
10/23/2000 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20261S24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S24ltr.pdf
10/14/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/08/1999 SUPPL-22 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm
05/14/1999 SUPPL-21 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S021_LESCOL_CAPSULES.pdf
04/21/1999 SUPPL-20 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S020_LESCOL_CAPSULES.pdf
01/04/1999 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S019_LESCOL_CAPSULES.pdf
03/08/1999 SUPPL-18 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm
08/05/1998 SUPPL-17 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S017_LESCOL_TABLETS.pdf
04/23/1998 SUPPL-16 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S016_LESCOL_TABLETS.pdf
11/20/1997 SUPPL-15 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S016_LESCOL_TABLETS.pdf
04/21/1997 SUPPL-14 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S014_LESCOL.pdf
06/16/1997 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S013_LESCOL.pdf
10/01/1997 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

10/08/1998 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S011_LESCOL_CAPSULES.pdf
04/30/1996 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020261_S010_LESCOL.pdf
02/08/1996 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S009_LESCOL_CAPSULES.pdf
12/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-7 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S007_LESCOL_CAPSULES.pdf
03/20/1996 SUPPL-6 Efficacy-New Dosing Regimen

Label is not available on this site.

05/03/1995 SUPPL-5 Labeling

Label is not available on this site.

11/10/1994 SUPPL-4 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S004_LESCOL_AP.pdf
11/28/1994 SUPPL-3 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S003_LESCOL_AP.pdf
03/21/1994 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_s002_Lescol Capsules.pdf
03/13/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/04/2017 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020261s052,021192s026lbl.pdf
10/31/2012 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf
02/28/2012 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf
06/17/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf
06/12/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf
04/10/2006 SUPPL-36 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf
04/10/2006 SUPPL-35 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf
03/22/2006 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf
01/05/2005 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf
05/27/2003 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf
09/06/2002 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf
09/25/2001 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20261s30lbl.pdf
10/23/2000 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20261S24lbl.pdf
10/06/2000 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf

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