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FDA Drug Application 203045 by MERCK SHARP DOHME

Application Number203045
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/21/2011N31227000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/203045s000lbl.pdf 12/23/2011
AP012/21/2011N31272000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/203045s000ltr.pdf 12/27/2011
AP012/21/2011N32552000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045_isentress_toc.cfm 4/30/2012
AP012/21/2011N32553000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/203045Orig1s000SumR.pdf 4/30/2012
AP03/28/2012SE832262001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf 3/28/2012
AP03/28/2012SE832325001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf 4/2/2012
AP04/18/2012SE832493002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf 4/20/2012
AP04/18/2012SE832504002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf 4/23/2012
AP08/10/2012SLR33439003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf 8/15/2012
AP08/10/2012SLR33475003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf 8/15/2012
AP06/28/2013SE836430004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf 7/2/2013
AP06/28/2013SE836443004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf 7/3/2013
AP04/4/2013SLR35651005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf 4/9/2013
AP04/4/2013SLR35666005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf 4/9/2013
AP05/28/2013SCM       
AP08/5/2013SLR36698007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s007lbl.pdf 8/6/2013
AP08/5/2013SLR36711007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf 8/6/2013
AP010/24/2013SLR37562008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf 10/25/2013
AP010/24/2013SLR37583008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203045s008lbl.pdf 10/25/2013
AP012/20/2013SE838138009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf 12/23/2013
AP012/20/2013SE838200009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf 12/31/2013
AP04/8/2014SLR39021010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf 4/10/2014
AP04/8/2014SLR39028010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf 4/10/2014
AP02/18/2015SLR41875011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf 2/19/2015
AP02/18/2015SLR41885011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf 2/20/2015
AP02/20/2015SLR41894012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf 2/23/2015
AP02/20/2015SLR41910012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf 2/24/2015




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