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FDA Drug Application 022468 by ALLOS

Application Number022468
Application Type New Drug Application
Sponsor ApplicantALLOS
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
AP09/24/2009N23451000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf 9/25/2009
AP09/24/2009N23460000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022468s000ltr.pdf 9/29/2009
AP09/24/2009N24111000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022468s000TOC.cfm 11/23/2009
AP04/26/2010SLR25361001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf 4/28/2010
AP04/26/2010SLR25389001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022468s001ltr.pdf 4/29/2010
AP01/7/2011SLR27501003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf 1/10/2011
AP01/7/2011SLR27530003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf 1/14/2011
AP01/7/2011SLR27531004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf 1/14/2011
AP01/7/2011SLR27502004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf 1/10/2011
AP01/7/2011SLR27503005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf 1/10/2011
AP01/7/2011SLR27532005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf 1/14/2011
AP02/15/2012SLR31807009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s009ltr.pdf 2/17/2012
AP02/15/2012SLR31822009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf 2/17/2012
AP05/30/2012SLR32789010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf 6/4/2012
AP05/30/2012SLR32830010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf 6/6/2012
AP05/30/2012SLR32831011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf 6/6/2012
AP05/30/2012SLR32790011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf 6/4/2012
AP05/13/2016SLR46031012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022468Orig1s012ltr.pdf 5/16/2016
AP05/13/2016SLR46042012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf 5/17/2016




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