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FDA Drug Application 009435 by FRESENIUS KABI USA

Application Number009435
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/1955N       
AP03/16/1976SLR       
AP03/16/1976SLR       
AP011/15/1974SCS       
AP011/6/1980SLR       
AP02/27/1979SCS       
AP06/13/1979SCS       
AP02/23/1981SCP       
AP02/23/1981SLR       
AP07/16/1985SCF       
AP07/16/1985SCF       
AP07/16/1985SPD       
AP02/12/1982SCS       
AP02/12/1982SCS       
AP011/14/1986SLR       
AP08/6/1986SCM       
AP07/30/1987SCS       
AP07/30/1987SLR       
AP07/30/1987SLR       
AP08/26/1988SLR       
AP03/5/1990SCM       
AP08/27/1990SCS       
AP04/13/1993SCS       
AP04/5/1995SCS       
AP05/2/1996SCF       
AP05/31/1996SCM       
AP011/10/2000SLR       
AP02/15/2002SCS       
AP06/21/2004SLR9488034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf 6/22/2004
AP06/21/2004SLR9502034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09435slr034ltr.pdf 6/23/2004
AP02/19/2010SLR24854035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf 2/25/2010
AP02/19/2010SLR25061035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf 3/18/2010
AP02/19/2010SLR24855036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf 2/25/2010
AP02/19/2010SLR25062036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf 3/18/2010
AP02/16/2013SCM       




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