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FDA Drug Application 019339 by HOSPIRA

Application Number019339
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
AP03/27/1985N       
AP04/1/1986SCP       
AP09/24/1986SCM       
AP08/3/1986SCM       
AP010/29/1986SCF       
AP02/16/1990SCS       
AP02/18/1992SCP       
AP02/25/1992SCM       
AP011/10/1994SCF       
AP011/10/1994SCP       
AP011/10/1994SCM       
AP011/10/1994SCP       
AP08/22/1995SCP       
AP08/30/1996SCM       
AP08/24/1995SCM       
AP02/7/1996SCP       
AP05/27/1998SLR       
AP06/9/1997SCM       
AP03/16/1998SLR       
AP010/27/1998SCS       
AP010/27/1998SCS       
AP011/19/1999SLR       
AP011/7/2002SCP       
AP010/17/2008SLR21033034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019339s034ltr.pdf 10/21/2008
AP07/23/2009SLR23098038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf 7/31/2009
AP012/23/2011SLR31264047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019339s047lbl.pdf 12/23/2011
AP012/23/2011SLR31296047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019339s047ltr.pdf 12/29/2011
AP02/8/2013SCM       
AP03/13/2014SLR38805054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019339Orig1s054ltr.pdf 3/18/2014
AP03/13/2014SLR38847054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf 3/19/2014




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