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FDA Drug Application 009190 by GUERBET

Application Number009190
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
AP03/31/1954N       
AP02/7/1978SCS       
AP011/14/1979SCM       
AP011/14/1979SCS       
AP09/10/1985SLR       
AP03/21/2014SLR38873021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s021ltr.pdf 3/24/2014
AP03/21/2014SLR38889021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf 3/25/2014
AP01/23/2014SCM       
AP04/4/2014SE838986024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s024ltr.pdf 4/7/2014
AP04/4/2014SE839000024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf 4/8/2014




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