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FDA Drug Application 018916 by HOSPIRA

Application Number018916
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
AP01/31/1984N       
AP09/24/1984SLR       
AP04/16/1985SCP       
AP010/29/1985SCF       
AP010/29/1985SCF       
AP08/8/1986SCM       
AP010/29/1986SCF       
AP08/21/1987SCP       
AP06/23/1989SE2       
AP010/24/1988SLR       
AP02/16/1990SCS       
AP010/29/1990SCS       
AP02/18/1992SCP       
AP02/25/1992SCM       
AP010/2/1991SLR       
AP08/30/1996SCM       
AP09/5/1996SCM       
AP02/7/1996SCP       
AP08/29/1996SCP       
AP04/3/1997SCM       
AP08/25/1998SLR       
AP06/9/1997SCM       
AP06/25/1997SCM       
AP08/29/1997SCP       
AP010/27/1998SCS       
AP011/19/1999SLR       
AP012/23/2011SLR31267057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf 12/23/2011
AP012/23/2011SLR31295057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018916s057ltr.pdf 12/29/2011
AP011/30/2012SCM       
AP02/12/2013SLR35157060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018916Orig1s060ltr.pdf 2/13/2013
AP02/12/2013SLR35171060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf 2/14/2013
AP02/8/2013SCM       
AP07/15/2013SCM       
AP01/15/2014SCM       
AP04/5/2016SLR45602066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf 4/7/2016
AP04/5/2016SLR45656066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf 4/12/2016
AP03/3/2015SCM       
AP04/14/2015SCM       
AP04/5/2016SLR45601069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf 4/7/2016
AP04/5/2016SLR45657069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf 4/12/2016
AP07/18/2016SCM       




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