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FDA Drug Application 006488 by FRESENIUS KABI USA

Application Number006488
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/19/1948N       
AP012/4/1972SLR       
AP05/20/1974SCS       
AP06/24/1974S       
AP08/28/1975SLR       
AP08/28/1975SCS       
AP07/16/1975SCS       
AP010/9/1975SLR       
AP02/2/1976SCM       
AP05/17/1978SLR       
AP03/26/1979SCS       
AP04/9/1979SCS       
AP04/9/1979SLR       
AP02/27/1979SCS31533019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/006488Orig1s019.pdf 1/27/2012
AP012/31/1980SLR       
AP08/29/1979SLR       
AP04/17/1980SCS       
AP010/1/1981SCS       
AP07/26/1982SCS       
AP07/26/1982SLR       
AP010/1/1981SLR       
AP012/12/1984SPD       
AP02/22/1986SCS       
AP02/22/1986SLR       
AP03/25/1982SCS       
AP06/28/1982SCM       
AP012/3/1984SLR       
AP03/22/1985SCS       
AP03/22/1985SLR       
AP03/21/1991SCS       
AP03/21/1991SLR       
AP011/13/1986SCS       
AP011/13/1986SLR       
AP08/29/1986SCS       
AP08/29/1986SLR       
AP02/27/1986SLR       
AP05/19/1986SLR       
AP09/16/1987SCM       
AP03/18/1987SLR       
AP09/11/1987SCS       
AP09/11/1987SLR       
AP012/2/1988SCP       
AP012/2/1988SLR       
AP07/11/1989SCP       
AP010/2/1990SCS       
AP010/20/1993SCE       
AP02/18/1993SCM       
AP04/13/1993SCS       
AP011/21/1994SCM       
AP07/11/1995SCS       
AP07/18/1995SCE       
AP012/8/1997SCP       
AP01/3/1996SCM       
AP05/31/1996SCM       
AP05/2/1996SCS       
AP05/26/1999SLR       
AP03/6/1998SCM       
AP012/14/2000SCS       
AP012/8/2000SCS       
AP07/17/2002SCS       
AP02/19/2010SLR24853074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf 2/25/2010
AP02/19/2010SLR25066074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006488s074ltr.pdf 3/18/2010
AP06/11/2013SCM       
AP04/9/2013SCM       
AP010/29/2013SCM       
AP02/16/2013SCM       
AP03/28/2013SLR       
AP02/13/2013SCM       
AP02/20/2013SCM       
AP07/22/2013SCM       
AP012/26/2013SCM       
AP03/3/2015SCM       
AP03/17/2016SCM       




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