Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019766
Company: MSD MERCK CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOCOR SIMVASTATIN 5MG TABLET;ORAL Prescription AB Yes No
ZOCOR SIMVASTATIN 10MG TABLET;ORAL Prescription AB Yes No
ZOCOR SIMVASTATIN 20MG TABLET;ORAL Prescription AB Yes No
ZOCOR SIMVASTATIN 40MG TABLET;ORAL Prescription AB Yes No
ZOCOR SIMVASTATIN 80MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1991 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
02/28/2018 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019766Orig1s098ltr.pdf
03/01/2016 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

02/02/2015 SUPPL-93 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf
03/01/2019 SUPPL-92 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019766Orig1s092ltr.pdf
02/27/2014 SUPPL-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf
10/25/2013 SUPPL-90 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf
10/31/2012 SUPPL-88 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf
10/31/2012 SUPPL-87 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf
11/15/2012 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

02/28/2012 SUPPL-85 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf
10/06/2011 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf
06/08/2011 SUPPL-82 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf
11/04/2010 SUPPL-81 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf
04/08/2010 SUPPL-80 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf
06/10/2011 SUPPL-79 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
03/02/2010 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf
06/08/2011 SUPPL-77 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766s077.pdf
06/11/2008 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf
11/26/2007 SUPPL-75 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf
06/01/2007 SUPPL-74 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf
05/17/2005 SUPPL-70 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf
08/31/2005 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf
02/24/2004 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf
02/24/2004 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf
09/17/2003 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf
09/17/2003 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf
04/16/2003 SUPPL-58 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019766_S058_ZOCOR_TABS_AP.pdf
05/06/2002 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2002 SUPPL-56 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-056ltr.pdf
02/22/2002 SUPPL-55 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S055_ZOCOR.pdf
03/21/2002 SUPPL-54 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S054_ZOCOR.pdf
11/14/2001 SUPPL-53 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S053_ZOCOR.pdf
03/21/2002 SUPPL-52 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-766s052_Zocor.cfm
05/06/2002 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf
09/13/2001 SUPPL-50 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S050_ZOCOR.pdf
06/04/2001 SUPPL-49 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S049_ZOCOR.pdf
04/10/2001 SUPPL-48 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S048_ZOCOR.pdf
04/10/2001 SUPPL-47 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S047_ZOCOR.pdf
11/14/2001 SUPPL-45 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S045_ZOCOR.pdf
12/11/2000 SUPPL-44 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S044_ZOCOR_TABLET.pdf
04/14/2000 SUPPL-43 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S043_ZOCOR_TABLETS.pdf
11/07/2000 SUPPL-42 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

03/15/2000 SUPPL-41 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_s041_ZOCOR_TABLETS.pdf
04/27/2000 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor.cfm
08/22/2000 SUPPL-39 Labeling

Label is not available on this site.

11/22/1999 SUPPL-36 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf
09/15/1999 SUPPL-35 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s035_ZOCOR TABLETS.pdf
11/22/1999 SUPPL-34 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf
03/22/1999 SUPPL-33 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_S033_ZOCOR_TABLET.pdf
08/05/1999 SUPPL-32 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf
04/23/1999 SUPPL-31 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s031_ZOCOR_TABLETS.pdf
09/24/1998 SUPPL-30 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766_S030_ZOCOR_TABLETS.pdf
06/29/1998 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766a_s029.pdf
07/10/1998 SUPPL-28 Efficacy-New Dosing Regimen Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm
03/31/1998 SUPPL-27 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766s027_Zocor.cfm
07/10/1998 SUPPL-26 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm
12/02/1997 SUPPL-25 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S025_ZOCOR_TABLETS.pdf
09/09/1997 SUPPL-23 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S023_ZOCOR_TABLETS.pdf
07/18/1997 SUPPL-22 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S022_ZOCOR_TABLETS.pdf
10/31/1997 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

08/12/1997 SUPPL-20 Labeling

Label is not available on this site.

03/17/1997 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1997 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766a_s018.pdf
05/23/1997 SUPPL-17 Labeling

Label is not available on this site.

11/22/1996 SUPPL-16 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_S016_ZOCOR_TABLETS.pdf
08/01/1995 SUPPL-15 Labeling

Label is not available on this site.

06/09/1995 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s014_ZOCOR_TABLETS.pdf
11/06/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1995 SUPPL-12 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s012_ZOCOR_TABLETS.pdf
06/30/1995 SUPPL-11 Efficacy-New Indication

Label is not available on this site.

02/16/1995 SUPPL-10 Labeling

Label is not available on this site.

12/21/1994 SUPPL-9 Labeling

Label is not available on this site.

04/19/1995 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s008_ZOCOR_TABLETS.pdf
07/28/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/23/1995 SUPPL-6 Labeling

Label is not available on this site.

02/22/1994 SUPPL-5 Labeling

Label is not available on this site.

11/24/1993 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1994 SUPPL-3 Labeling

Label is not available on this site.

08/09/1993 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1992 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
03/01/2019 SUPPL-92 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s092lbl.pdf
02/28/2018 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf
02/02/2015 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf
02/27/2014 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf
10/25/2013 SUPPL-90 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf
10/31/2012 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf
10/31/2012 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf
02/28/2012 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf
10/06/2011 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf
06/08/2011 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf
06/08/2011 SUPPL-77 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf
11/04/2010 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf
04/08/2010 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf
03/02/2010 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf
06/11/2008 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf
11/26/2007 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf
06/01/2007 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf
06/01/2007 SUPPL-74 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf
08/31/2005 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf
05/17/2005 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf
02/24/2004 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf
02/24/2004 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf
09/17/2003 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf
09/17/2003 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf
04/16/2003 SUPPL-58 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf
10/18/2002 SUPPL-56 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf
05/06/2002 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf
03/21/2002 SUPPL-52 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf
11/14/2001 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf
04/27/2000 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf

ZOCOR

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 090383 MICRO LABS
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 5MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 090383 MICRO LABS
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 10MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 090383 MICRO LABS
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 20MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 090383 MICRO LABS
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 40MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 090383 MICRO LABS
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 80MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

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