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FDA Drug Application 018905 by GUERBET

Application Number018905
Application Type New Drug Application
Sponsor ApplicantGUERBET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/26/1985N       
AP06/3/1988SCP       
AP010/22/1986SE1       
AP011/21/1986SLR       
AP012/30/1986SLR       
AP010/10/1989SCP       
AP01/31/1989SCM       
AP07/3/1989SLR       
AP03/30/1990SCS       
AP03/30/1994SCM       
AP012/4/1992SCS       
AP03/17/1994SCS       
AP08/28/1992SCP       
AP01/13/1995SLR       
AP04/26/1995SCM       
AP010/27/1999SCF       
AP02/23/2001SCP       
AP07/6/2015SLR43292024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf 7/9/2015
AP07/6/2015SLR43312024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018905Orig1s024ltr.pdf 7/10/2015




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