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FDA Drug Application 017029 by FRESENIUS KABI USA

Application Number017029
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
AP02/22/1972N       
AP08/29/1975SCS       
AP02/9/1976SCS       
AP03/17/1976SCS       
AP01/9/1976SCF       
AP01/9/1976SCS       
AP02/9/1976SLR       
AP06/16/1976SCM       
AP012/4/1977SLR       
AP01/26/1977SCF       
AP012/3/1976SCF       
AP012/3/1976SCS       
AP012/14/1977SCS       
AP05/23/1978SLR       
AP011/21/1978SCS       
AP011/21/1978SCS       
AP010/31/1979SCM       
AP010/31/1979SCS       
AP03/24/1981SCM       
AP02/24/1981SLR       
AP09/17/1982SCS       
AP05/6/1982SLR       
AP09/21/1982SCM       
AP09/21/1982SCM       
AP01/4/1983SCE       
AP011/2/1983SCE       
AP011/2/1983SCF       
AP05/16/1985SCF       
AP011/2/1983SCF       
AP011/2/1983SCF       
AP011/2/1983SCF       
AP011/2/1983SCF       
AP012/5/1985SCP       
AP012/5/1985SCP       
AP012/5/1985SCP       
AP012/5/1985SCP       
AP012/5/1985SCP       
AP012/5/1985SCP       
AP011/6/1984SCP       
AP07/29/1985SES       
AP09/22/1987SCP       
AP09/22/1987SCP       
AP04/7/1986SLR       
AP04/28/1986SCS       
AP06/26/1992SLR       
AP012/1/1989SCP       
AP02/16/1988SCS       
AP09/22/1988SLR       
AP06/8/1989SCP       
AP08/6/1998SCM       
AP08/6/1998SCM       
AP08/25/1993SLR       
AP07/26/1996SCS       
AP010/27/1994SCM       
AP05/17/1995SCM       
AP08/6/1998SCM       
AP06/24/1997SCS       
AP011/4/1997SCS       
AP03/8/2000SCP       
AP012/13/1999SCM       
AP03/22/2002SLR2211099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17029s099ltr.pdf 3/22/2002
AP09/23/2008SLR20890108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017029s108ltr.pdf 9/26/2008
AP09/23/2008SLR20940108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf 10/3/2008
AP06/11/2010SLR25731120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf 6/14/2010
AP06/11/2010SLR25780120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf 6/24/2010
AP06/24/2011SLR29389128   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf 7/5/2011
AP012/23/2015SCM       
AP012/23/2011SLR31262131   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf 12/23/2011
AP012/23/2011SLR31292131   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf 12/29/2011
AP03/9/2015SCM       
AP03/21/2014SLR38983135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf 4/7/2014
AP09/24/2013SCM       
AP07/21/2015SCM       
AP06/9/2016SCM       




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