Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020261
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LESCOL | FLUVASTATIN SODIUM | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| LESCOL | FLUVASTATIN SODIUM | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |