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FDA Drug Application 205123 by JANSSEN PRODS

Application Number205123
Application Type New Drug Application
Sponsor ApplicantJANSSEN PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/22/2013N37909000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s000ltr.pdf 11/25/2013
AP011/22/2013N37943000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s000lbledt.pdf 11/26/2013
AP011/22/2013N38162000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000TOC.cfm 12/24/2013
AP011/22/2013N38163000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000SumR.pdf 12/24/2013
AP012/5/2013SLR37978001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf 12/6/2013
AP012/5/2013SLR37987001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s001ltr.pdf 12/9/2013
AP011/5/2014SE840956002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s002ltr.pdf 11/7/2014
AP011/5/2014SE840959002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s002lbledt.pdf 11/7/2014
AP09/5/2014SLR40448003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s003ltr.pdf 9/8/2014
AP09/5/2014SLR40458003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf 9/9/2014
AP03/3/2015SCM       
AP010/5/2015SE844176005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s005lbl.pdf 10/8/2015
AP010/5/2015SE844121005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s005ltr.pdf 10/6/2015
AP010/5/2015SE844122006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s006ltr.pdf 10/6/2015
AP010/5/2015SE844732006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s006lbl.pdf 12/10/2015
AP06/19/2015SCM       
AP04/15/2015SLR42540008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s008lbl.pdf 4/16/2015
AP04/15/2015SLR42548008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s008ltr.pdf 4/17/2015
AP04/15/2015SLR43694008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205123Orig1s008.pdf 8/21/2015
AP04/10/2015SLR42515009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s009ltr.pdf 4/13/2015
AP04/10/2015SLR42519009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s009lbl.pdf 4/14/2015
AP02/26/2016SE845300010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s010ltr.pdf 3/2/2016
AP02/26/2016SE845364010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s010lbl.pdf 3/3/2016
AP05/20/2016SE846109011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s011lbl.pdf 5/23/2016
AP05/20/2016SE846126011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s011ltr.pdf 5/24/2016




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