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FDA Drug Application 203684 by BRACCO

Application Number203684
Application Type New Drug Application
Sponsor ApplicantBRACCO
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
AP010/10/2014N40771000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203684Orig1s000ltr.pdf 10/15/2014
AP010/10/2014N41172000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000TOC.cfm 12/5/2014
AP010/10/2014N41173000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000SumR.pdf 12/5/2014
AP010/10/2014N41175000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000Lbl.pdf 12/5/2014
AP03/31/2016S45573001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203684Orig1s001ltr.pdf 4/4/2016
AP03/31/2016S45585001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203684s001lbl.pdf 4/5/2016




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