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FDA Drug Application 022523 by JANSSEN PHARMS

Application Number022523
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/12/2010N25252000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf 4/12/2010
AP04/12/2010N25253000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523MedGuide.pdf 4/12/2010
AP04/12/2010N25262000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022523s000ltr.pdf 4/14/2010
AP04/12/2010N27418000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523_pancreaze_toc.cfm 1/3/2011
AP04/12/2010N27898000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523Orig1s000SumR.pdf 2/17/2011
AP06/20/2011SLR29357002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022523s002ltr.pdf 6/29/2011
AP012/7/2012SCM       
AP03/7/2014SCM38733004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf 3/10/2014
AP03/7/2014SCM38745004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022523Orig1s004ltr.pdf 3/11/2014
AP05/27/2014SCM39369005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf 5/28/2014
AP06/23/2014SCM       
AP05/16/2016SCM       
AP03/3/2015SCM       
AP03/30/2015SCM       
AP08/4/2016SCM       




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