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FDA Drug Application 202439 by JANSSEN PHARMS

Application Number202439
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type 10
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/4/2011N39421000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439toc.cfm 6/3/2014
AP011/4/2011N39422000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf 6/3/2014
AP011/4/2011N39423000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf 6/3/2014
AP04/3/2013SCM       
AP02/12/2014SLR       
AP011/5/2012SLR       
AP08/7/2013SLR36730008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202439Orig1s008ltr.pdf 8/8/2013
AP08/7/2013SLR36763008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf 8/9/2013
AP05/15/2014SCM       
AP02/12/2014SLR38514012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf 2/13/2014
AP02/16/2015SCM       
AP09/10/2015SLR43851015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202439s015lbl.pdf 9/11/2015
AP09/10/2015SLR43857015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202439Orig1s015ltr.pdf 9/14/2015
AP05/6/2016SE845888017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s017ltr.pdf 5/9/2016
AP05/6/2016SE845890017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s017lbl.pdf 5/9/2016
AP08/24/2016SCM       
AP09/6/2016SLR46986019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s019ltr.pdf 9/7/2016
AP010/5/2016SLR47353020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s020ltr.pdf 10/14/2016




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