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FDA Drug Application 019465 by HOSPIRA

Application Number019465
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
AP07/15/1985N       
AP01/17/1986SL       
AP05/27/1986SC       
AP08/8/1986SC       
AP011/26/1986SC       
AP02/6/1989SC       
AP09/20/1989SL       
AP07/18/1989SC       
AP08/3/1989SC       
AP02/22/1990SC       
AP03/9/1990SC       
AP01/11/1990SC       
AP011/2/1990SC       
AP02/16/1993SL       
AP09/10/1991SC       
AP01/28/1992SC       
AP012/30/1991SC       
AP02/25/1994SC       
AP06/21/1994SL       
AP01/5/1995SC       
AP09/23/1994SC       
AP01/24/1996SC       
AP08/27/1996SC       
AP05/31/1995SC       
AP03/4/1996SC       
AP07/2/1999SL       
AP06/11/1997SC       
AP08/20/1997SC       
AP012/1/1998SC       
AP04/6/2000SCP       
AP04/6/2000SL       
AP04/6/2000SCE       
AP011/1/2002SCP       
AP06/10/2016SLR46320054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf 6/14/2016
AP09/27/2016SLR47223055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s55ltr.pdf 9/30/2016
AP09/27/2016SLR47228055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019465s055lbl.pdf 9/30/2016




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