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FDA Drug Application 204781 by GUERBET

Application Number204781
Application Type New Drug Application
Sponsor ApplicantGUERBET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/20/2013N35492000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204781Orig1s000ltr.pdf 3/22/2013
AP03/20/2013N35534000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781s000lbl.pdf 3/26/2013
AP03/20/2013N36025000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000TOC.cfm 5/10/2013
AP03/20/2013N36026000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000SumR.pdf 5/10/2013




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