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FDA Drug Application 019345 by HOSPIRA

Application Number019345
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
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
AP01/26/1985N       
AP01/31/1986SC       
AP08/13/1985SC       
AP08/29/1986SC       
AP02/13/1987SC       
AP02/13/1987SL       
AP08/8/1986SC       
AP011/26/1986SC       
AP02/6/1989SC       
AP02/22/1990SC       
AP01/11/1990SC       
AP09/10/1991SC       
AP01/28/1992SC       
AP01/21/1993SC       
AP012/13/1993SC       
AP08/27/1996SC       
AP08/18/1995SC       
AP03/4/1996SC       
AP08/6/1996SC       
AP03/28/1997SC       
AP08/20/1997SL       
AP06/11/1997SC       
AP012/1/1998SC       
AP05/27/1999SL       
AP011/1/2002SCP       
AP02/22/2016SLR45244044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf 2/23/2016
AP02/22/2016SLR45255044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf 2/24/2016




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