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FDA Drug Application 084916 by FRESENIUS KABI USA

Application Number084916
Application Type Abbreviated 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
AP09/6/1977N       
AP04/19/1982SC       
AP012/6/1983SC       
AP01/17/1984SC       
AP01/3/1985SC       
AP01/3/1985SC       
AP012/6/1984SC       
AP06/13/1986SC       
AP011/2/1988SL       
AP07/12/1989SL       
AP02/6/1991SL       
AP09/13/1991SCI       
AP06/13/1991SL       
AP01/11/1994SLI       
AP07/20/1995SL       
AP06/13/2001SCR       
AP012/5/2002SCB       
AP07/3/2014SLR43492066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084916s066lbl.pdf 7/27/2015
AP07/3/2014SLR43501066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf 7/28/2015




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