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FDA Drug Application 018902 by FRESENIUS KABI USA

Application Number018902
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
AP05/22/1984N       
AP011/5/1985SC       
AP07/16/1986SC       
AP08/10/1988SC       
AP01/11/1990SL       
AP04/18/1995SC       
AP02/16/1990SL       
AP08/10/1995SC       
AP08/10/1995SL       
AP04/22/1997SL       
AP08/8/1997SL       
AP010/15/1997SL       
AP01/11/1999SC       
AP01/2/2001SCE       
AP07/1/2015SCM       
AP03/8/2016SLR45406027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s027ltr.pdf 3/10/2016
AP03/8/2016SLR45431027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf 3/14/2016
AP09/19/2016SLR47131028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s028ltr.pdf 9/21/2016




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