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FDA Drug Application 125433 by JANSSEN BIOTECH

Application Number125433
Application Type Biologic License Application
Sponsor ApplicantJANSSEN BIOTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/18/2013N36585000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125433s000lbledt.pdf 7/22/2013
AP07/18/2013N36599000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362202.pdf 7/24/2013
AP07/18/2013N36606000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125433Orig1s000ltr.pdf 7/26/2013
AP07/18/2013N37262000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125433review.pdf 9/30/2013
AP02/4/2014SLR38462002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s002lbl.pdf 2/6/2014
AP02/4/2014SLR38488002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s002ltr.pdf 2/11/2014
AP02/12/2014SLR38511005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s005lbl.pdf 2/12/2014
AP02/12/2014SLR38515005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s005ltr.pdf 2/13/2014
AP012/19/2014SLR41396013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s013ltr.pdf 12/24/2014
AP08/5/2015SE843584014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125433s014lbl.pdf 8/6/2015
AP08/5/2015SE843600014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125433Orig1s014ltr.pdf 8/10/2015
AP01/8/2016SLR44952015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s015ltr.pdf 1/11/2016
AP01/8/2016SLR44961015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s015lbl.pdf 1/12/2016
AP04/26/2016SLR45764016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s016ltr.pdf 4/27/2016
AP04/26/2016SLR45834016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s016lbl.pdf 5/3/2016
AP02/22/2016SLR45242017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s017lbl.pdf 2/23/2016
AP02/22/2016SLR45251017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s017ltr.pdf 2/24/2016
AP08/19/2016SLR46830018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s018ltr.pdf 8/22/2016
AP08/19/2016SLR46859018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s018lbl.pdf 8/23/2016




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