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FDA Drug Application 010040 by BRACCO

Application Number010040
Application Type New Drug Application
Sponsor ApplicantBRACCO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/2/1955N       
AP06/17/1977SCS       
AP05/27/1975SOA       
AP09/30/1975SLR       
AP09/30/1975SLR       
AP09/24/1975SCS       
AP05/6/1976SLR       
AP05/6/1976SLR       
AP05/5/1976SCE       
AP05/5/1976SLR       
AP05/5/1976SLR       
AP05/6/1976SLR       
AP05/6/1976SCE       
AP06/16/1976SLR       
AP05/26/1976SCS       
AP09/10/1976SLR       
AP09/9/1976SLR       
AP09/13/1976SLR       
AP09/13/1976SLR       
AP09/6/1976SLR       
AP09/10/1976SLR       
AP09/10/1976SLR       
AP09/13/1976SLR       
AP01/31/1978SLR       
AP012/2/1976SLR       
AP012/14/1976SCP       
AP08/22/1977SLR       
AP012/6/1976SLR       
AP01/11/1977SCP       
AP01/11/1977SCS       
AP01/11/1977SLA       
AP03/30/1979SCS       
AP010/21/1977SLR       
AP011/1/1977SLR       
AP03/14/1978SLR       
AP09/15/1978SCS       
AP02/23/1978SCS       
AP012/28/1978SCF       
AP02/16/1979SCS       
AP06/26/1979SLR       
AP09/13/1979SLR       
AP03/19/1980SLR       
AP09/13/1979SLR       
AP010/12/1979SLR       
AP010/12/1979SLR       
AP01/24/1980SCS       
AP06/8/1979SLR       
AP06/8/1979SLR       
AP06/8/1979SLR       
AP06/30/1980SLR       
AP06/30/1982SLR       
AP07/10/1983SES       
AP08/3/1979SCS       
AP01/26/1983SLR       
AP03/14/1980SLR       
AP06/30/1982SLR       
AP06/4/1980SLR       
AP04/14/1980SLR       
AP06/20/1980SLR       
AP07/1/1980SLR       
AP06/4/1980SLR       
AP08/1/1980SFP       
AP07/1/1981SCS       
AP09/27/1982SES       
AP03/31/1982SLR       
AP03/5/1991SCF       
AP02/24/1982SCS       
AP011/9/1982SCS       
AP01/14/1985SCS       
AP01/6/1984SCP       
AP02/2/1983SLR       
AP05/23/1985SCM       
AP04/3/1984SES       
AP05/23/1985SCM       
AP01/28/1985SCM       
AP06/12/1985SLR       
AP06/6/1985SLR       
AP06/12/1985SLR       
AP06/12/1985SLR       
AP07/23/1985SLR       
AP06/6/1985SLR       
AP07/23/1985SLR       
AP07/23/1985SLR       
AP06/6/1985SLR       
AP06/5/1985SLR       
AP06/6/1985SLR       
AP07/23/1985SLR       
AP07/23/1985SLR       
AP011/25/1985SLR       
AP06/8/1987SCS       
AP07/7/1989SLR       
AP09/25/2003SPD6731163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10040spd163ltr.pdf 10/1/2003
AP09/9/1994SLR       
AP06/29/2000SCM       
AP010/23/2002SLR3157168   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10040slr168ltr.pdf 10/23/2002
AP07/6/2015SLR43311171   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010040Orig1s171ltr.pdf 7/10/2015
AP07/6/2015SLR43352171   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf 7/13/2015




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