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FDA Drug Application 022145 by MERCK SHARP DOHME

Application Number022145
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/12/2007N18242000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022145lbl.pdf 10/15/2007
AP010/12/2007N18283000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022145s000tr.pdf 10/22/2007
AP010/12/2007N19253000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_Isentress.cfm 2/22/2008
AP010/12/2007N19254000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_SumR.pdf 2/22/2008
AP01/30/2009SE721716001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf 2/3/2009
AP11/29/2009SLR21716001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf 2/3/2009
AP01/30/2009SE721791001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf 2/4/2009
AP11/29/2009SLR21791001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf 2/4/2009
AP01/30/2009SE721796001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf 2/9/2009
AP11/29/2009SLR21796001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf 2/9/2009
AP010/24/2008SLR21093003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022145s003ltr.pdf 10/28/2008
AP010/24/2008SLR21195003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022145s003lbl.pdf 11/7/2008
AP07/8/2009SE522918004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s004lbl.pdf 7/9/2009
AP07/8/2009SE522969004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s004ltr.pdf 7/15/2009
AP07/8/2009SE532421004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022145Orig1s004.pdf 4/13/2012
AP01/13/2009SLR21631006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s006ltr.pdf 1/14/2009
AP01/13/2009SLR21636006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf 1/14/2009
AP06/29/2010SE825901011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf 7/2/2010
AP06/29/2010SE825919011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf 7/6/2010
AP06/29/2010SE825920012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf 7/6/2010
AP06/29/2010SE825902012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf 7/2/2010
AP011/4/2009SLR24094013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf 11/23/2009
AP011/4/2009SLR24563013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s013ltr.pdf 1/20/2010
AP03/26/2010SLR25181014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s014ltr.pdf 4/2/2010
AP03/26/2010SLR25202014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf 4/4/2010
AP06/10/2011SLR29214015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP02/24/2011SLR27994017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s017ltr.pdf 3/1/2011
AP02/24/2011SLR28050017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s017lbl.pdf 3/4/2011
AP04/11/2011SLR28526018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s018lbl.pdf 4/11/2011
AP04/11/2011SLR28538018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s018ltr.pdf 4/13/2011
AP011/2/2011SLR30524020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s020ltr.pdf 11/7/2011
AP011/2/2011SLR30634020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf 11/16/2011
AP03/28/2012SE832263021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf 3/28/2012
AP03/28/2012SE832324021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf 4/2/2012
AP012/21/2011SE531228022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s022lbl.pdf 12/23/2011
AP012/21/2011SE531274022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s022ltr.pdf 12/28/2011
AP04/18/2012SE832494023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf 4/20/2012
AP04/18/2012SE832503023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf 4/23/2012
AP08/10/2012SLR33438026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf 8/15/2012
AP08/10/2012SLR33476026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf 8/15/2012
AP06/28/2013SE836429027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf 7/2/2013
AP06/28/2013SE836444027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf 7/3/2013
AP04/4/2013SLR35652028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf 4/9/2013
AP04/4/2013SLR35665028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf 4/9/2013
AP08/5/2013SLR36697029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf 8/5/2013
AP08/5/2013SLR36710029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf 8/6/2013
AP010/24/2013SLR37561030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf 10/25/2013
AP012/20/2013SE838137031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf 12/23/2013
AP012/20/2013SE838199031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf 12/31/2013
AP04/8/2014SLR39020032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf 4/10/2014
AP04/8/2014SLR39029032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf 4/10/2014
AP010/10/2014SCM       
AP02/18/2015SLR41876034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf 2/19/2015
AP02/18/2015SLR41886034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf 2/20/2015
AP02/20/2015SLR41895035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf 2/23/2015
AP02/20/2015SLR41911035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf 2/24/2015




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