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FDA Drug Application 202344 by MISSION PHARMA

Application Number202344
Application Type New Drug Application
Sponsor ApplicantMISSION PHARMA
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
AP03/12/2012N35858000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344_binosto_toc.cfm 4/29/2013
AP03/12/2012N35859000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202344Orig1s000SumR.pdf 4/29/2013
AP03/12/2012N32188000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202344s000ltr.pdf 3/26/2012
AP03/12/2012N33600000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202344s000lbl.pdf 8/30/2012
AP03/12/2012N33601000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM318435.pdf 8/30/2012
AP04/19/2013SLR35777001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202344Orig1s001ltr.pdf 4/23/2013
AP04/19/2013SLR35809001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s001lbl.pdf 4/23/2013
AP08/2/2013SCM36759002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202344s002lbl.pdf 8/9/2013
AP04/17/2013SCM       
AP012/23/2013SCM       
AP02/26/2015SLR41951007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s007ltr.pdf 2/27/2015
AP02/26/2015SLR41991007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s007lbl.pdf 3/3/2015
AP04/8/2015SLR42483008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf 4/10/2015
AP04/8/2015SLR42509008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202344Orig1s008ltr.pdf 4/13/2015
AP01/26/2016SCM       
AP03/22/2016SLR45495010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202344Orig1s010ltr.pdf 3/24/2016




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