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FDA Drug Application 008809 by HOSPIRA

Application Number008809
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/1953N       
AP09/20/1984SLR       
AP04/25/1985SCP       
AP04/24/1985SCP       
AP08/8/1985SLR       
AP06/22/1989SLR       
AP012/7/1990SCP       
AP04/19/1991SLR       
AP02/2/1993SCP       
AP02/3/1993SCP       
AP02/24/1993SCS       
AP05/26/1995SCS       
AP010/27/1995SCS       
AP01/19/1996SCS       
AP02/13/1997SCS       
AP09/22/1997SCS       
AP03/30/1998SCM       
AP012/31/1997SCP       
AP05/12/1998SCP       
AP011/18/1998SCS       
AP05/25/1999SCS       
AP08/2/1999SCS       
AP04/10/2001SCM       
AP04/17/2001SCM       
AP04/17/2001SCM       
AP06/4/2002SLR3652046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8809s046ltr.pdf 6/4/2002
AP06/4/2002SCS       
AP011/14/2002SCS       
AP04/22/2004SCF8426052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809scf052ltr.pdf 4/29/2004
AP04/22/2004SCF8476052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809scf052_mvi-12_lbl.pdf 5/4/2004
AP09/9/2004SE110182054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08809s054ltr.pdf 9/10/2004
AP09/9/2004SE110183054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08809s054lbl.pdf 9/10/2004
AP06/14/2012SLR32910065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008809s065ltr.pdf 6/15/2012
AP06/14/2012SLR32931065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/008809s065lbl.pdf 6/18/2012
AP03/26/2013SLR35551066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008809Orig1s066ltr.pdf 3/28/2013
AP03/26/2013SLR35593066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008809s066lbl.pdf 4/1/2013
AP02/3/2015SCM       
AP03/19/2013SCM       
AP09/18/2015SCM       




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