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FDA Drug Application 017651 by FRESENIUS KABI USA

Application Number017651
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
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
AP02/10/1978N17316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017651_ORIGINAL APPROVAL_PACKAGE.pdf 7/20/2007
AP011/15/1978SCS       
AP01/8/1979SCS       
AP07/13/1979SCS       
AP01/8/1979SDS       
AP010/3/1979SCS       
AP01/8/1979SCS       
AP05/29/1979SCS       
AP01/25/1980SDS       
AP09/18/1979SCS       
AP010/18/1979SCF       
AP01/21/1980SDS       
AP06/2/1981SCS       
AP04/6/1982SCM       
AP01/12/1983SCM       
AP012/19/1983SES       
AP06/26/1984SES       
AP010/4/1984SLR       
AP09/19/1984SCM       
AP07/29/1985SLR       
AP01/8/1985SCM       
AP010/19/1988SLR       
AP02/9/1989SLR       
AP08/25/1993SLR       
AP07/26/1996SCS       
AP07/12/1995SCS       
AP07/31/1992SLR       
AP012/22/1992SLR       
AP012/22/1997SCM       
AP012/13/1999SCM       
AP01/7/2003SCM       
AP012/14/2007SLR18834042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017651s042ltr.pdf 1/9/2008
AP04/1/2009SLR22203046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017651s046ltr.pdf 4/3/2009
AP04/1/2009SLR22213046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017651s046lbl.pdf 4/3/2009
AP06/11/2010SLR25732048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf 6/14/2010
AP06/11/2010SLR25779048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf 6/24/2010
AP06/24/2011SLR29390052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf 7/5/2011
AP012/23/2011SLR31261055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf 12/23/2011
AP012/23/2011SLR31293055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf 12/29/2011
AP02/16/2013SCM       
AP03/20/2013SCM       
AP011/13/2015SCM       
AP03/21/2014SLR38984059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf 4/7/2014
AP07/18/2013SCM       




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