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FDA Drug Application 018735 by BRACCO

Application Number018735
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1985N       
AP03/5/1986SCE       
AP09/10/1986SE1       
AP010/21/1986SE1       
AP01/28/1987SCM       
AP06/26/1986SLR       
AP09/24/1986SCF       
AP02/24/1987SCM       
AP07/7/1987SE1       
AP07/2/1987SCM       
AP01/18/1990SE5       
AP02/6/1989SCP       
AP010/4/1989SE5       
AP02/6/1989SCS       
AP012/7/1988SCP       
AP09/18/1989SCM       
AP04/24/1989SCS       
AP05/15/1989SLR       
AP011/19/1990SCP       
AP011/27/1990SCP       
AP05/30/1990SE5       
AP01/3/1991SCP       
AP09/21/1990SE5       
AP07/29/1991SLR       
AP07/6/1992SE2       
AP09/30/1992SCP       
AP09/30/1992SLR       
AP012/21/1992SCS       
AP03/4/1996SE2       
AP09/9/1993SCP       
AP03/21/1994SCS       
AP05/15/1995SE5       
AP05/15/1995SLR       
AP09/29/1995SLR       
AP06/24/1996SCM       
AP03/19/1997SCS       
AP05/14/1997SCM       
AP07/8/2002SLR1935043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr043ltr.pdf 7/8/2002
AP06/20/2002SLR1936044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf 6/20/2002
AP011/16/1999SCM       
AP012/9/1999SCM       
AP06/1/2000SCM       
AP010/7/2003SCS       
AP012/1/2005SCS       
AP07/26/2005SCM       
AP03/10/2006SCP       
AP08/1/2012SLR33346054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf 8/2/2012
AP08/1/2012SLR33347054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018735Orig1s054ltr.pdf 8/3/2012
AP05/14/2015SCM       
AP07/6/2015SLR43284056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf 7/9/2015
AP07/6/2015SLR43293056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf 7/9/2015




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