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FDA Drug Application 021445 by MSD INTL GMBH

Application Number021445
Application Type New Drug Application
Sponsor ApplicantMSD INTL GMBH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/25/2002N2053000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21445ltr.pdf 10/25/2002
AP010/25/2002N2054000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf 10/25/2002
AP010/25/2002N7187000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm 2/3/2003
AP010/25/2002N18955000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079524.htm 1/25/2008
AP07/23/2004SLR9848001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf 7/28/2004
AP07/23/2004SLR9878001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf 7/28/2004
AP07/23/2004SLR19222001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf 2/19/2008
AP012/10/2007SCM       
AP07/23/2004SLR9849003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf 7/28/2004
AP07/23/2004SLR9879003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf 7/28/2004
AP07/23/2004SLR19223003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf 2/19/2008
AP07/23/2004SLR9850004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s001,003,004ltr.pdf 7/28/2004
AP07/23/2004SLR9880004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21445s001,003,004lbl.pdf 7/28/2004
AP07/23/2004SLR19224004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf 2/19/2008
AP09/22/2004SLR10279006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21445s006ltr.pdf 9/27/2004
AP03/2/2005SLR11221007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s007ltr.pdf 3/10/2005
AP03/2/2005SLR11232007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s007lbl.pdf 3/10/2005
AP03/22/2005SLR11294011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21445s011ltr.pdf 3/29/2005
AP03/22/2005SLR11308011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21445s011lbl.pdf 3/29/2005
AP03/16/2006SE813776012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf 3/22/2006
AP03/16/2006SE813797012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf 3/23/2006
AP05/23/2006SE114165013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s013lbl.pdf 5/24/2006
AP05/23/2006SE114174013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s013LTR.pdf 5/25/2006
AP01/19/2006SLR13512014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s014lbl.pdf 1/27/2006
AP01/19/2006SLR13551014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s014ltr.pdf 1/30/2006
AP03/16/2006SLR13777015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s012,s015lbl.pdf 3/22/2006
AP03/16/2006SLR13798015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s012,s015ltr.pdf 3/23/2006
AP011/2/2006SLR15292016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021445s016lbl.pdf 11/6/2006
AP011/2/2006SLR15307016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021445s016ltr.pdf 11/6/2006
AP012/10/2007SLR18661018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021445s018lbl.pdf 12/14/2007
AP012/10/2007SLR18857018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021445s018ltr.pdf 1/9/2008
AP02/7/2008SLR19079019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s019ltr.pdf 2/13/2008
AP02/7/2008SLR19114019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf 2/14/2008
AP06/5/2008SE519968020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf 6/9/2008
AP06/5/2008SE519995020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf 6/12/2008
AP06/5/2008SLR19969021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021445s020,021ltr.pdf 6/9/2008
AP06/5/2008SLR19996021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s020s021lbl.pdf 6/12/2008
AP01/27/2009SCP21778025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf 2/4/2009
AP01/27/2009SCP21779025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s025ltr.pdf 2/4/2009
AP07/21/2009SLR23060026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf 7/23/2009
AP07/21/2009SLR24134026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf 11/25/2009
AP07/21/2009SLR23061027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s026s027lbl.pdf 7/23/2009
AP07/21/2009SLR24135027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021445s026,s027ltr.pdf 11/25/2009
AP07/29/2011SLR29773030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021445s030lbl.pdf 8/12/2011
AP07/29/2011SLR29777030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021445s030ltr.pdf 8/12/2011
AP01/24/2012SE831517033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021445s033lbl.pdf 1/25/2012
AP01/24/2012SE831571033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021445s033ltr.pdf 1/30/2012
AP01/11/2013SCM       
AP02/15/2013SCM       
AP06/4/2013SCM       
AP09/30/2014SLR40763037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021445Orig1s037ltr.pdf 10/14/2014
AP09/30/2014SLR40895037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021445Orig1s037lbl.pdf 10/30/2014




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