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FDA Drug Application 017697 by BRACCO

Application Number017697
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/21/1976N       
AP09/14/1977SCS       
AP010/18/1979SCS       
AP08/25/1986SE1       
AP07/15/1985SCM       
AP05/25/1988SLR       
AP012/22/1992SLR       
AP010/29/2002SCM       
AP011/27/2002SCM9144012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf 6/7/2004
AP011/27/2002SCM34347012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s012.pdf 11/9/2012
AP011/27/2002SCF9145013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf 6/7/2004
AP011/27/2002SCF34348013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s013.pdf 11/9/2012
AP011/27/2002SCP9146014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf 6/7/2004
AP011/27/2002SCP34349014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s014.pdf 11/9/2012
AP011/27/2002SCS9147015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf 6/7/2004
AP011/27/2002SCS34350015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s015.pdf 11/9/2012
AP04/26/2005SLR11534017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017697s017ltr.pdf 4/28/2005
AP07/18/2014SCM       
AP01/22/2015SCM       
AP05/29/2015SCM       
AP08/18/2015SCM       
AP02/17/2016SCM       
AP08/17/2016SCM       




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