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FDA Drug Application 204153 by MEDICIS

Application Number204153
Application Type New Drug Application
Sponsor ApplicantMEDICIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/14/2013N37824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204153Orig1s000ltr.pdf 11/15/2013
AP011/14/2013N37827000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf 11/15/2013
AP011/14/2013N38017000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000TOC.cfm 12/12/2013
AP011/14/2013N38018000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000SumR.pdf 12/12/2013
AP06/7/2016SCM       




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