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FDA Drug Application 202022 by JANSSEN PRODS

Application Number202022
Application Type New Drug Application
Sponsor ApplicantJANSSEN PRODS
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
AP05/20/2011N28888000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf 5/23/2011
AP05/20/2011N28907000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202022s000ltr.pdf 5/24/2011
AP05/20/2011N29395000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000TOC.cfm 7/5/2011
AP05/20/2011N29396000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000SumR.pdf 7/5/2011
AP012/7/2012SE134575002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s002lbl.pdf 12/10/2012
AP012/7/2012SE134594002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s002ltr.pdf 12/11/2012
AP08/10/2012SLR33441003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s003ltr.pdf 8/15/2012
AP08/10/2012SLR33473003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s003lbl.pdf 8/15/2012
AP04/26/2013SCM       
AP06/19/2013SLR36362005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202022Orig1s005ltr.pdf 6/21/2013
AP06/19/2013SLR36383005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202022s005lbl.pdf 6/25/2013
AP07/23/2013SCM       
AP05/1/2014SLR39197007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202022s007lbl.pdf 5/2/2014
AP05/1/2014SLR39220007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202022Orig1s007ltr.pdf 5/6/2014
AP08/26/2015SE843738008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s008lbledt.pdf 8/27/2015
AP08/26/2015SE843742008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s008ltr.pdf 8/28/2015
AP05/5/2015SLR42747009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s009lbl.pdf 5/7/2015
AP05/5/2015SLR42762009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s009ltr.pdf 5/11/2015




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