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FDA Drug Application 021880 by CELGENE

Application Number021880
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/2005N13300000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf 12/28/2005
AP012/27/2005N13301000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109337.htm 12/28/2005
AP012/27/2005N13355000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021880rev2.pdf 1/6/2006
AP012/27/2005N13595000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021880s000_RevlimidTOC.cfm 2/8/2006
AP012/27/2005N24067000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111335.pdf 11/20/2009
AP012/27/2005N26226000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=46 8/16/2010
AP06/29/2006SE114393001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf 7/3/2006
AP06/29/2006SE114463001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf 7/13/2006
AP02/23/2009SLR21906006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf 2/24/2009
AP02/23/2009SLR21930006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf 3/3/2009
AP08/3/2010SLR26126013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s013ltr.pdf 8/9/2010
AP08/3/2010SLR26185013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf 8/10/2010
AP02/23/2009SLR21907016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf 2/24/2009
AP02/23/2009SLR21931016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf 3/3/2009
AP02/23/2009SLR21908017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf 2/24/2009
AP02/23/2009SLR21932017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf 3/3/2009
AP010/12/2010SE826671018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s018ltr.pdf 10/19/2010
AP010/12/2010SE826704018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf 10/19/2010
AP012/21/2011SE831229023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf 12/23/2011
AP012/21/2011SE831276023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021880s023ltr.pdf 12/28/2011
AP03/12/2012SLR32093028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf 3/12/2012
AP03/12/2012SLR32106028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s028ltr.pdf 3/14/2012
AP02/8/2013SE835135029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf 2/12/2013
AP02/8/2013SE835146029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf 2/12/2013
AP12/8/2013S35135029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf 2/12/2013
AP12/8/2013S35146029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf 2/12/2013
AP05/9/2012SLR32677031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf 5/10/2012
AP05/9/2012SLR32678031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031mg.pdf 5/10/2012
AP05/9/2012SLR32680031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s031ltr.pdf 5/11/2012
AP02/8/2013SLR35134033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf 2/12/2013
AP02/8/2013SLR35147033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf 2/12/2013
AP06/5/2013SE136230034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf 6/5/2013
AP06/5/2013SE136233034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s034ltr.pdf 6/6/2013
AP011/15/2013S37841035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s035ltr.pdf 11/18/2013
AP012/19/2013SCM       
AP011/4/2013SLR37686038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf 11/4/2013
AP011/4/2013SLR37725038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s038ltr.pdf 11/7/2013
AP09/12/2014SLR40488039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf 9/16/2014
AP09/12/2014SLR40515039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf 9/19/2014
AP09/12/2014SLR40489040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf 9/16/2014
AP09/12/2014SLR40516040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf 9/19/2014
AP02/17/2015SE141870041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf 2/19/2015
AP02/17/2015SE141904041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf 2/24/2015
AP09/13/2015SE843873044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s044ltr.pdf 9/15/2015
AP010/27/2015SE844327045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s045ltr.pdf 10/29/2015
AP012/1/2015SE844647046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s046ltr.pdf 12/2/2015
AP04/22/2016S45747047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021880Orig1s047ltr.pdf 4/26/2016




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