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FDA Drug Application 019805 by HOSPIRA

Application Number019805
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
AP01/25/1989N       
AP02/16/1990SCS       
AP010/16/1990SCM       
AP02/18/1992SCP       
AP02/25/1992SCM       
AP08/30/1996SCM       
AP09/5/1996SCM       
AP08/24/1995SCM       
AP08/29/1996SCP       
AP05/27/1998SLR       
AP011/25/1997SCS       
AP03/16/2000SLR       
AP09/18/2002SCE       
AP012/23/2011SLR31265029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019805s029lbl.pdf 12/23/2011
AP012/23/2011SLR31313029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019805s029ltr.pdf 1/3/2012
AP02/8/2013SCM       
AP03/13/2014SLR38806036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019805Orig1s036ltr.pdf 3/18/2014
AP03/13/2014SLR38846036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019805s036lbl.pdf 3/19/2014




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