Back to FDA Applications sponsored by CELGENE

FDA Drug Application 204026 by CELGENE

Application Number204026
Application Type New Drug Application
Sponsor ApplicantCELGENE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/8/2013N35120000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf 2/8/2013
AP02/8/2013N35121000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026s000mg.pdf 2/8/2013
AP02/8/2013N35128000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf 2/11/2013
AP02/8/2013N35137000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=41 2/12/2013
AP02/8/2013N35481000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000TOC.cfm 3/20/2013
AP02/8/2013N35482000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf 3/20/2013
AP010/3/2013SCM       
AP011/15/2013SE837838002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf 11/18/2013
AP03/13/2014SLR38825003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf 3/19/2014
AP03/13/2014SLR38850003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf 3/19/2014
AP09/12/2014SLR40485004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf 9/16/2014
AP04/23/2015SLR42643005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf 4/24/2015
AP04/23/2015SLR42678005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf 4/28/2015
AP04/23/2015SE842644006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf 4/24/2015
AP04/23/2015SE842679006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf 4/28/2015
AP04/23/2015SLR42645008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf 4/24/2015
AP04/23/2015SLR42680008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf 4/28/2015
AP09/14/2015SLR43883009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf 9/16/2015
AP010/27/2015SE844323010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf 10/28/2015
AP012/1/2015S44644011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf 12/2/2015
AP06/30/2016SLR46451012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf 7/1/2016
AP06/30/2016SLR46459012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf 7/5/2016
AP16/30/2016SLR46451012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf 7/1/2016
AP16/30/2016SLR46459012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf 7/5/2016
AP04/22/2016S45739013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf 4/25/2016
AP06/30/2016SLR46450014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf 7/1/2016
AP06/30/2016SLR46460014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf 7/5/2016




Back to FDA Applications sponsored by CELGENE