Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021445
Company: MSD INTL GMBH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZETIA EZETIMIBE 10MG 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
10/25/2002 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21445ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021445Orig1s037ltr.pdf
06/04/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/11/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/24/2012 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021445s033ltr.pdf
07/29/2011 SUPPL-30 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021445s030ltr.pdf
07/21/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf
07/21/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf
01/27/2009 SUPPL-25 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s025ltr.pdf
06/05/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf
06/05/2008 SUPPL-20 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf
02/07/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s019ltr.pdf
12/10/2007 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021445s018ltr.pdf
11/02/2006 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s016ltr.pdf
03/16/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf
01/19/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s014ltr.pdf
05/23/2006 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s013LTR.pdf
03/16/2006 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf
03/22/2005 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s011ltr.pdf
03/02/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s007ltr.pdf
09/22/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s006ltr.pdf
07/23/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf
07/23/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf
12/10/2007 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/23/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf
01/24/2012 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf
07/29/2011 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf
07/21/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf
07/21/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf
01/27/2009 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf
01/27/2009 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf
06/05/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf
06/05/2008 SUPPL-20 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf
02/07/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf
12/10/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf
11/02/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf
05/23/2006 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf
03/16/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf
03/16/2006 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf
01/19/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf
03/22/2005 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf
03/02/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf
07/23/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf
07/23/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf
07/23/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf
10/25/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf

ZETIA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 209234 ALKEM LABS LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 208803 AMNEAL PHARMS CO
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 208332 APOTEX INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 209838 AUROBINDO PHARMA LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 078560 GLENMARK PHARMS LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 201790 MYLAN
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 207311 OHM LABS INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 203931 SANDOZ INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 078724 TEVA PHARMS USA
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 200831 WATSON LABS INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 204331 ZYDUS PHARMS
ZETIA EZETIMIBE 10MG TABLET;ORAL Prescription Yes AB 021445 MSD INTL GMBH

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