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FDA Drug Application 019316 by FRESENIUS KABI USA

Application Number019316
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
AP09/8/1986N       
AP06/19/1987SCP       
AP011/13/1987SCP       
AP09/16/1991SLR       
AP03/1/2000SCS       
AP012/12/1994SCS       
AP02/28/1995SCS       
AP02/7/1996SCS       
AP010/28/1998SLR       
AP012/5/2006SLR15475011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019316s011lbl.pdf 12/14/2006
AP012/5/2006SLR15567011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019316s011ltr.pdf 12/28/2006
AP05/29/2013SLR36159018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019316Orig1s018ltr.pdf 5/30/2013
AP05/29/2013SLR36217018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf 6/4/2013
AP02/29/2016SCM       
AP06/19/2015SCM       
AP01/29/2016SCM       




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