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FDA Drug Application 009321 by BRACCO

Application Number009321
Application Type New Drug Application
Sponsor ApplicantBRACCO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/27/1954N       
AP012/2/1976SLR       
AP07/5/1977SCP       
AP05/16/1977SCS       
AP010/1/1979SLR       
AP04/12/1982SLR       
AP08/6/1985SCM       
AP04/29/1994SCS       
AP05/11/1995SLR       
AP03/16/2000SCM       
AP07/6/2015SLR43283028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009321Orig1s028ltr.pdf 7/9/2015
AP07/6/2015SLR43351028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf 7/13/2015




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