Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019643
Company: MERCK
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| MEVACOR | LOVASTATIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MEVACOR | LOVASTATIN | 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MEVACOR | LOVASTATIN | 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |