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FDA Drug Application 022393 by CELGENE

Application Number022393
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
AP011/5/2009N23745000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022393lbl.pdf 11/6/2009
AP011/5/2009N23867000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022393s000ltr.pdf 11/13/2009
AP011/5/2009N24391000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000TOC.cfm 1/4/2010
AP011/5/2009N24392000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000_SumR.pdf 1/4/2010
AP04/12/2011SLR28547001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s001ltr.pdf 4/15/2011
AP04/12/2011SLR28553001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf 4/15/2011
AP06/16/2011SE129189004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf 6/16/2011
AP06/16/2011SE129266004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s004ltr.pdf 6/27/2011
AP09/30/2011SLR30174006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s006lbl.pdf 9/30/2011
AP09/30/2011SLR30199006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s006ltr.pdf 10/3/2011
AP06/13/2013SLR36293011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022393Orig1s011ltr.pdf 6/14/2013
AP06/13/2013SLR36306011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022393s011lbl.pdf 6/18/2013
AP09/13/2013SCM       
AP010/15/2014SE840820013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022393s013lbl.pdf 10/16/2014
AP010/15/2014SE840836013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022393Orig1s013ltr.pdf 10/21/2014
AP07/27/2016SLR46669014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf 7/28/2016
AP07/27/2016SLR46688014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022393Orig1s014ltr.pdf 8/1/2016




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