Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019643
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEVACOR LOVASTATIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MEVACOR LOVASTATIN 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MEVACOR LOVASTATIN 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/31/1987 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2014 SUPPL-88 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019643Orig1s088ltr.pdf
10/31/2012 SUPPL-87 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf
10/31/2012 SUPPL-86 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf
02/28/2012 SUPPL-85 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643s085ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019643s085.pdf
02/02/2011 SUPPL-84 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019643s084ltr.pdf
06/10/2011 SUPPL-82 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
06/30/2010 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019643s081ltr.pdf
03/09/2009 SUPPL-80 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019643s080ltr.pdf
12/07/2007 SUPPL-79 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s079ltr.pdf
05/29/2007 SUPPL-78 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s078ltr.pdf
06/13/2005 SUPPL-77 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s077ltr.pdf
11/04/2005 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s076ltr.pdf
04/07/2005 SUPPL-75 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19643s075ltr.pdf
10/17/2003 SUPPL-73 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019643_S073_MEVACOR_TABLETS_AP.pdf
09/20/2002 SUPPL-71 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643slr071ltr.pdf
09/23/2002 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/22/2001 SUPPL-69 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf
01/30/2002 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2002 SUPPL-67 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643s067ltr.pdf
06/26/2001 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/01/2001 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2001 SUPPL-64 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf
04/26/2001 SUPPL-62 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf
04/17/2007 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s061_LTR.pdf
09/14/2000 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

08/22/2000 SUPPL-59 Labeling

Label is not available on this site.

03/01/1999 SUPPL-57 Labeling

Label is not available on this site.

08/28/1998 SUPPL-56 Labeling

Label is not available on this site.

03/11/1999 SUPPL-55 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor.cfm
06/29/1998 SUPPL-54 Labeling

Label is not available on this site.

04/22/1998 SUPPL-53 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf
11/20/1997 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1997 SUPPL-51 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf
08/12/1997 SUPPL-50 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s050.pdf
03/27/1997 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/06/1997 SUPPL-47 Labeling

Label is not available on this site.

12/26/1996 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1996 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1995 SUPPL-44 Labeling

Label is not available on this site.

08/08/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1995 SUPPL-42 Efficacy-New Dosing Regimen

Label is not available on this site.

01/23/1995 SUPPL-41 Labeling

Label is not available on this site.

02/09/1996 SUPPL-40 Labeling

Label is not available on this site.

08/01/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/21/1994 SUPPL-37 Labeling

Label is not available on this site.

07/05/1994 SUPPL-36 Labeling

Label is not available on this site.

12/20/1994 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1995 SUPPL-34 Efficacy-New Indication

Label is not available on this site.

05/17/1994 SUPPL-33 Labeling

Label is not available on this site.

05/17/1994 SUPPL-32 Labeling

Label is not available on this site.

08/09/1993 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1992 SUPPL-30 Labeling

Label is not available on this site.

11/23/1993 SUPPL-28 Labeling

Label is not available on this site.

11/24/1993 SUPPL-27 Labeling

Label is not available on this site.

12/17/1992 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1992 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1991 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/22/1993 SUPPL-21 Labeling

Label is not available on this site.

10/24/1991 SUPPL-20 Labeling

Label is not available on this site.

03/28/1991 SUPPL-18 Efficacy-New Dosing Regimen

Label is not available on this site.

12/19/1991 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019643_S017_MEVACOR_TABLETS_AP.pdf
04/10/1991 SUPPL-15 Labeling

Label is not available on this site.

03/12/1991 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1991 SUPPL-12 Labeling

Label is not available on this site.

10/20/1989 SUPPL-11 Labeling

Label is not available on this site.

02/21/1991 SUPPL-10 Labeling

Label is not available on this site.

12/14/1988 SUPPL-9 Labeling

Label is not available on this site.

12/20/1988 SUPPL-8 Labeling

Label is not available on this site.

03/21/1989 SUPPL-7 Labeling

Label is not available on this site.

11/22/1988 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/1988 SUPPL-4 Labeling

Label is not available on this site.

07/06/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/01/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2014 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf
10/31/2012 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
10/31/2012 SUPPL-86 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf
02/28/2012 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf
02/02/2011 SUPPL-84 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf
06/30/2010 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf
03/09/2009 SUPPL-80 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf
03/09/2009 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf
05/29/2007 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf
04/17/2007 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf
11/04/2005 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf
06/13/2005 SUPPL-77 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf
04/07/2005 SUPPL-75 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf
09/20/2002 SUPPL-71 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf
02/14/2002 SUPPL-67 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf
10/22/2001 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf
04/26/2001 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf

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