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FDA Drug Application 022510 by SENTYNL THERAPS INC

Application Number022510
Application Type New Drug Application
Sponsor ApplicantSENTYNL THERAPS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/7/2011N27506000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf 1/10/2011
AP01/7/2011N27517000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239930.pdf 1/13/2011
AP01/7/2011N27521000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 1/14/2011
AP01/7/2011N27533000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s000ltr.pdf 1/14/2011
AP01/7/2011N30470000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510_abstral_toc.cfm 11/2/2011
AP01/7/2011N30472000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510Orig1s000SumR.pdf 11/2/2011
AP012/28/2011SLR31328003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf 1/3/2012
AP012/28/2011SLR31365003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf 1/6/2012
AP06/5/2012SLR32852005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf 6/7/2012
AP06/5/2012SLR32885005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf 6/11/2012
AP011/7/2013SE837788007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf 11/12/2013
AP07/26/2013SLR36644010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf 7/30/2013
AP07/26/2013SLR36653010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf 7/30/2013
AP010/2/2013SCM       
AP011/4/2014SLR40953013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf 12/24/2014
AP011/4/2014SLR40964013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf 11/7/2014
AP012/24/2014S41451014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf 12/30/2014




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