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FDA Drug Application 018826 by HOSPIRA

Application Number018826
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
AP09/30/1983N       
AP01/4/1984SCP       
AP06/27/1984SCP       
AP01/4/1984SCE       
AP09/18/1984SCS       
AP09/18/1984SCS       
AP04/1/1986SCP       
AP09/24/1986SCM       
AP010/29/1986SCF       
AP08/13/1987SLR       
AP07/25/1990SCM       
AP011/15/1990SCP       
AP07/18/1991SCP       
AP012/31/1991SCP       
AP05/7/1992SLR       
AP06/14/1994SCP       
AP07/7/1994SLR       
AP08/17/1995SCP       
AP06/26/1996SCS       
AP04/14/1995SLR       
AP08/3/1995SCM       
AP04/8/1998SLR       
AP09/7/1997SCS       
AP011/16/1998SCS       
AP06/5/1999SLR       
AP04/10/2001SLR4851027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18826S27ltr.pdf 4/3/2003
AP04/10/2001SLR6158027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-826S027.pdf 7/28/2003
AP011/5/2002SCP       
AP012/16/2013SCM       
AP05/14/2014SLR39308045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf 5/15/2014
AP05/14/2014SLR39318045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826Orig1s045ltr.pdf 5/19/2014




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