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FDA Drug Application 017643 by FRESENIUS

Application Number017643
Application Type New Drug Application
Sponsor ApplicantFRESENIUS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/7/1975N       
AP03/28/1977SLR       
AP08/28/1978SCS       
AP03/15/1978SCS       
AP09/6/1978SCS       
AP09/6/1978SLR       
AP07/10/1978SCS       
AP03/6/1978SCS       
AP012/28/1977SLR       
AP04/25/1979SCS       
AP04/25/1979SLR       
AP011/8/1978SLR       
AP01/30/1979SCS       
AP04/9/1979SCS       
AP04/9/1979SCS       
AP01/2/1980SCS       
AP010/23/1979SCS       
AP09/7/1979SCS       
AP07/9/1979SCS       
AP08/16/1979SLR       
AP012/14/1979SCE       
AP02/26/1980SLR       
AP010/15/1979SCS       
AP012/14/1979SLR       
AP09/28/1979SLR       
AP010/15/1979SCS       
AP05/14/1980SCM       
AP07/11/1980SLR       
AP02/10/1984SCS       
AP06/20/1981SLR       
AP06/17/1981SCS       
AP01/27/1982SCS       
AP06/7/1983SLR       
AP05/27/1983SLR       
AP05/27/1983SCS       
AP09/19/1988SLR       
AP05/2/1984SCS       
AP07/27/1984SCS       
AP01/31/1985SCS       
AP01/29/1985SCS       
AP04/10/1989SCM       
AP06/20/1990SCM       
AP06/6/1990SLR       
AP05/18/1994SCS       
AP08/24/1993SCS       
AP011/8/1991SCP       
AP02/17/1995SCS       
AP012/20/2000SLR       
AP04/29/1997SCS       
AP03/18/1999SCM       
AP07/21/1999SCS       
AP09/27/2000SCS       
AP08/22/2001SCM       
AP04/16/2004SCS8383070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf 4/20/2004
AP04/24/2007SLR16287072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf 4/25/2007
AP04/24/2007SLR16421072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf 5/1/2007
AP012/15/2014SCM       
AP04/21/2016SCM       
AP05/31/2016SCM       




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