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FDA Drug Application 021825 by APOPHARMA INC

Application Number021825
Application Type New Drug Application
Sponsor ApplicantAPOPHARMA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/14/2011N30330000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf 10/14/2011
AP010/14/2011N30331000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021825Orig1s000ltr.pdf 10/14/2011
AP010/14/2011N30799000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000TOC.cfm 11/30/2011
AP010/14/2011N30844000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000SumR.pdf 12/2/2011
AP04/20/2012SLR32508001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021825s001lbl.pdf 4/24/2012
AP04/20/2012SLR32525001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021825s001ltr.pdf 4/24/2012
AP011/15/2012SCM       
AP02/24/2015SLR41916003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021825Orig1s003ltr.pdf 2/26/2015
AP02/24/2015SLR41961003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf 3/2/2015




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