Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021687
Company: MSD INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription AB Yes No
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription AB Yes No
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription AB Yes No
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;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
07/23/2004 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21687ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2017 SUPPL-57 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021687Orig1s057.pdf
02/02/2015 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021687s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021687Orig1s053ltr.pdf
09/30/2014 SUPPL-51 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s051ltr.pdf
02/27/2014 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021687s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s050ltr.pdf
10/25/2013 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021687s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021687Orig1s048ltr.pdf
10/31/2012 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf
10/31/2012 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf
02/28/2012 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s044ltr.pdf
12/01/2011 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s042ltr.pdf
10/06/2011 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021687Orig1s041.pdf
06/08/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf
01/24/2012 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s039ltr.pdf
12/22/2010 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s037ltr.pdf
04/22/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s036ltr.pdf
03/10/2010 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s034ltr.pdf
06/08/2011 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf
11/06/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s032ltr.pdf
01/30/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s030ltr.pdf
01/08/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s029ltr.pdf
06/13/2008 SUPPL-25 Labeling

Label is not available on this site.

06/13/2008 SUPPL-23 Efficacy-New Patient Population

Label is not available on this site.

02/08/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021687s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021687s022ltr.pdf
12/12/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s021ltr.pdf
05/16/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s019ltr.pdf
11/27/2006 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s016ltr.pdf
07/03/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s015LTR.pdf
03/16/2006 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf
10/03/2006 SUPPL-11 Efficacy-Accelerated Approval Confirmatory Study Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s011LTR.pdf
10/24/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s010ltr.pdf
12/09/2005 SUPPL-9 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s009ltr.pdf
03/16/2006 SUPPL-6 Efficacy-Accelerated Approval Confirmatory Study Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf
10/19/2005 SUPPL-4 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s004lbl.pdf
06/03/2005 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s003ltr.pdf
03/07/2005 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21687s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21687s002ltr.pdf
02/16/2005 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/02/2015 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021687s053lbl.pdf
02/27/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021687s050lbl.pdf
10/25/2013 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021687s048lbl.pdf
10/31/2012 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf
10/31/2012 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf
02/28/2012 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s044lbl.pdf
01/24/2012 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s039lbl.pdf
12/01/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s042lbl.pdf
10/06/2011 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s041lbl.pdf
06/08/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf
06/08/2011 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf
12/22/2010 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s037lbl.pdf
04/22/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s036lbl.pdf
03/10/2010 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s034lbl.pdf
11/06/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s032lbl.pdf
01/30/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s030lbl.pdf
01/08/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s029lbl.pdf
02/08/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021687s022lbl.pdf
12/12/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s021lbl.pdf
05/16/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s019lbl.pdf
11/27/2006 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s016lbl.pdf
10/24/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s010lbl.pdf
10/03/2006 SUPPL-11 Efficacy-Accelerated Approval Confirmatory Study Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s011lbl.pdf
07/03/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s015lbl.pdf
03/16/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf
03/16/2006 SUPPL-6 Efficacy-Accelerated Approval Confirmatory Study Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf
12/09/2005 SUPPL-9 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s009lbl.pdf
10/19/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s004lbl.pdf
06/03/2005 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s003lbl.pdf
03/07/2005 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21687s002lbl.pdf
07/23/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf

VYTORIN

TABLET;ORAL; 10MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 201890 IMPAX LABS INC
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription Yes AB 021687 MSD INTL

TABLET;ORAL; 10MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 201890 IMPAX LABS INC
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription Yes AB 021687 MSD INTL

TABLET;ORAL; 10MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 201890 IMPAX LABS INC
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription Yes AB 021687 MSD INTL

TABLET;ORAL; 10MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 201890 IMPAX LABS INC
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription Yes AB 021687 MSD INTL

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