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FDA Drug Application 008107 by HOSPIRA

Application Number008107
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/20/1952N       
AP08/15/1977SCS       
AP011/11/1977SCS       
AP03/9/1979SCS       
AP03/6/1979SCF       
AP03/6/1979SCS       
AP09/7/1979SCM       
AP07/25/1979SCF       
AP04/28/1980SCS       
AP01/16/1980SCS       
AP02/5/1980SCP       
AP09/4/1980SCM       
AP012/19/1980SCF       
AP012/22/1980SCF       
AP01/27/1981SCM       
AP03/27/1981SLR       
AP03/29/1983SLR       
AP02/22/1984SCS       
AP06/28/1984SCF       
AP01/30/1987SE2       
AP01/30/1987SE3       
AP01/30/1987SPD       
AP08/30/1988SLR       
AP05/23/1988SCF       
AP04/5/1989SCS       
AP08/31/1988SE1       
AP012/12/1991SE1       
AP03/10/1992SCP       
AP08/23/1989SCS       
AP09/11/1990SCS       
AP012/15/1992SLR       
AP01/26/1996SCS       
AP05/24/1996SLR       
AP07/21/1997SLR       
AP011/8/1999SCM       
AP02/12/2002SLR2780054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08107s54ltr.pdf 2/12/2002
AP02/12/2002SLR11979054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/08107s054_LeucovorinTOC.cfm 7/13/2005
AP012/17/2003SCM7292055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08-107scm055ltr.pdf 12/22/2003




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