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FDA Drug Application 022266 by BIODELIVERY SCI INTL

Application Number022266
Application Type New Drug Application
Sponsor ApplicantBIODELIVERY SCI INTL
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
AP07/16/2009N22993000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf 7/17/2009
AP07/16/2009N22994000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf 7/17/2009
AP07/16/2009N22995000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 7/17/2009
AP07/16/2009N22997000Prescriber Information  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000PrescriberInfo.pdf 7/17/2009
AP07/16/2009N23738000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266_onsolis_toc.cfm 11/5/2009
AP07/16/2009N23739000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266s000_SumR_P1.pdf 11/5/2009
AP07/16/2009N31309000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM285397.pdf 12/30/2011
AP07/16/2009N31220000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm284704.htm 12/22/2011
AP07/1/2010SLR25936001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf 7/8/2010
AP07/1/2010SLR25953001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf 7/12/2010
AP012/28/2011SLR31326008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf 1/3/2012
AP012/28/2011SLR31301008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf 12/28/2011
AP06/5/2012SLR32854009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022266s009ltr.pdf 6/7/2012
AP06/5/2012SLR32886009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf 6/11/2012
AP011/7/2013SLR37757012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022266Orig1s012ltr.pdf 11/8/2013
AP012/24/2014S41450014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022266Orig1s014ltr.pdf 12/30/2014
AP012/24/2014S41604014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf 1/9/2015
AP08/11/2015SCM43638015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf 8/12/2015




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