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FDA Drug Application 050794 by CELGENE

Application Number050794
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
AP05/19/2004N8571000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050794lbl.pdf 5/19/2004
AP05/19/2004N8626000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50794ltr.pdf 5/26/2004
AP05/19/2004N9936000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-794_Vidaza.cfm 8/5/2004
AP06/29/2005SLR11961001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050794s001ltr.pdf 7/8/2005
AP01/26/2007SE815732005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050794s005lbl.pdf 2/2/2007
AP02/22/2008SCM19296010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s010ltr.pdf 2/25/2008
AP08/20/2008SE820656011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s011ltr.pdf 8/22/2008
AP08/20/2008SE820687011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050794s011lbl.pdf 8/26/2008
AP08/17/2011SLR29830016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf 8/22/2011
AP08/17/2011SLR29865016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf 8/24/2011
AP08/17/2011SLR29831020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf 8/22/2011
AP08/17/2011SLR29866020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf 8/24/2011
AP01/24/2012SLR31519023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s023LBL.pdf 1/25/2012
AP01/24/2012SLR31532023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050794s023ltr.pdf 1/27/2012
AP012/19/2012SCM34746024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s024lbl.pdf 12/21/2012
AP05/6/2013SCM       
AP01/10/2014SLR38259026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050794s026lbledt.pdf 1/13/2014
AP01/10/2014SLR38262026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050794Orig1s026ltr.pdf 1/14/2014
AP02/23/2015SCM       
AP012/17/2015SLR44823028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050794Orig1s028ltr.pdf 12/18/2015
AP012/17/2015SLR44877028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050794s028lbl.pdf 12/24/2015
AP08/23/2016SLR46879029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050794Orig1s029ltr.pdf 8/24/2016
AP08/23/2016SLR46982029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050794s029lbl.pdf 9/7/2016




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