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FDA Drug Application 205395 by JANSSEN PRODS

Application Number205395
Application Type New Drug Application
Sponsor ApplicantJANSSEN PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/29/2015N41747000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205395s000lbl.pdf 1/30/2015
AP01/29/2015N41749000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205395Orig1s000ltr.pdf 2/2/2015
AP01/29/2015N46336000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000TOC.cfm 6/15/2016
AP01/29/2015N46337000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000SumR.pdf 6/15/2016
AP03/31/2016SLR45571001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s001ltr.pdf 4/4/2016
AP03/31/2016SLR45777001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf 4/27/2016
AP09/22/2016SLR47194002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s002lbl.pdf 9/29/2016
AP09/22/2016SLR47330002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s002ltr.pdf 10/12/2016




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