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FDA Drug Application 204353 by JANSSEN PHARMS

Application Number204353
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP08/8/2014N40189000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204353Orig1s000ltr.pdf 8/11/2014
AP08/8/2014N40210000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf 8/12/2014
AP08/8/2014N40407000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000TOC.cfm 9/3/2014
AP08/8/2014N40408000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf 9/3/2014
AP03/3/2015SLR42012002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s002ltr.pdf 3/4/2015
AP03/3/2015SLR42223002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf 3/20/2015
AP09/10/2015SE843847003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf 9/11/2015
AP09/10/2015SE843858003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s003ltr.pdf 9/14/2015
AP06/8/2015SCM       
AP05/20/2016SE846106006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf 5/23/2016
AP05/20/2016SE846124006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf 5/24/2016
AP012/23/2015SCM       
AP03/17/2016SCM       
AP03/28/2016SLR45535010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf 3/30/2016
AP03/28/2016SLR45537010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s010ltr.pdf 3/30/2016
AP04/14/2016SCM       
AP012/4/2015SLR44672012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s012ltr.pdf 12/8/2015
AP012/4/2015SLR44705012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf 12/8/2015
AP05/20/2016S46107015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf 5/23/2016
AP05/20/2016S46125015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf 5/24/2016
AP010/18/2016SCM       
AP08/17/2016SLR46805020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s020ltr.pdf 8/18/2016
AP08/17/2016SLR46837020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf 8/22/2016




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