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FDA Drug Application 009470 by FRESENIUS KABI USA

Application Number009470
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/2/1954N       
AP05/3/1972SLR       
AP03/5/1976SLR       
AP05/27/1976SCF       
AP01/12/1977SCS       
AP02/3/1977SLR       
AP012/14/1978SCS       
AP05/5/1980SCS       
AP05/5/1980SLR       
AP02/11/1981SCS       
AP07/29/1983SPD       
AP03/25/1982SCS       
AP06/20/1984SCM       
AP09/16/1987SCM       
AP09/14/1989SCP       
AP010/26/1993SCP       
AP02/18/1993SCM       
AP04/18/1994SLR       
AP04/29/1996SCS       
AP05/31/1996SCM       
AP09/24/2014SLR40597025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009470Orig1s025ltr.pdf 9/25/2014
AP09/24/2014SLR40636025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf 9/26/2014




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