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FDA Drug Application 202379 by JANSSEN BIOTECH

Application Number202379
Application Type New Drug Application
Sponsor ApplicantJANSSEN BIOTECH
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
AP04/28/2011N28623000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf 4/28/2011
AP04/28/2011N28681000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202379s000ltr.pdf 5/3/2011
AP04/28/2011N28985000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000TOC.cfm 5/27/2011
AP04/28/2011N28986000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000SumR.pdf 5/27/2011
AP07/3/2012SLR33089003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379s003ltr.pdf 7/9/2012
AP07/3/2012SLR33194003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s003lbl.pdf 7/13/2012
AP09/17/2012SLR33792004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s004lbl.pdf 9/17/2012
AP09/17/2012SLR33800004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s004ltr.pdf 9/20/2012
AP012/10/2012SE134605005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s005ltr.pdf 12/12/2012
AP012/10/2012SE134664005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s005lbl.pdf 12/14/2012
AP06/17/2013SCM38291006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202379Orig1s006.pdf 1/16/2014
AP09/12/2013SLR37094007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202379Orig1s007ltr.pdf 9/13/2013
AP09/12/2013SLR37116007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202379s007lbl.pdf 9/17/2013
AP02/7/2014SCM       
AP05/9/2014SLR39304009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202379s009lbl.pdf 5/15/2014
AP05/9/2014SLR39325009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202379Orig1s009ltr.pdf 5/19/2014
AP04/1/2014SCM       
AP04/17/2014SCM       
AP011/16/2014SCM       
AP01/20/2015SCM       
AP01/23/2015SLR41680015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s015ltr.pdf 1/26/2015
AP01/23/2015SLR41729015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s015lbl.pdf 1/29/2015
AP03/20/2015SE842239016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s016ltr.pdf 3/24/2015
AP03/20/2015SE842255016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf 3/24/2015
AP03/3/2015SCM       
AP05/20/2015SLR42881018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s018ltr.pdf 5/22/2015
AP05/20/2015SLR42916018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s018lbl.pdf 5/27/2015
AP08/18/2015SCM       
AP012/10/2015SLR44756021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s021ltr.pdf 12/11/2015
AP012/10/2015SLR44773021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s021lbl.pdf 12/15/2015
AP05/17/2016SLR46061023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202379Orig1s023ltr.pdf 5/19/2016
AP05/17/2016SLR46082023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202379s023lbl.pdf 5/20/2016




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