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FDA Drug Application 020327 by BRACCO

Application Number020327
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
AP010/12/1994N       
AP012/17/1996SCS       
AP06/20/2002SLR6131002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20327slr002ltr.pdf 7/23/2003
AP012/9/1999SCM       
AP012/5/2003SCS7145004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf 12/11/2003
AP07/26/2005SCM       
AP08/1/2012SLR33345007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf 8/2/2012
AP08/1/2012SLR33367007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020327Orig1s007ltr.pdf 8/3/2012
AP06/20/2014SLR39636008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf 6/23/2014
AP06/20/2014SLR39648008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020327Orig1s008ltr.pdf 6/24/2014
AP07/6/2015SLR43285010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf 7/9/2015
AP07/6/2015SLR43294010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf 7/9/2015
AP01/22/2016SLR45011011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020327Orig1s011ltr.pdf 1/25/2016
AP01/22/2016SLR45021011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf 1/26/2016




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