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FDA Drug Application 016964 by HOSPIRA

Application Number016964
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/3/1972N       
AP01/13/1976SLR       
AP06/10/1976SLR       
AP06/7/1976SCS       
AP06/10/1976SCS       
AP011/30/1976SFP       
AP07/7/1976SCM       
AP06/15/1978SCS       
AP06/15/1978SCS       
AP04/4/1979SCS       
AP08/21/1980SCS       
AP08/21/1980SLR       
AP04/4/1979SCS       
AP06/18/1979SLR       
AP012/6/1979SCS       
AP011/3/1980SLR       
AP01/27/1982SCS       
AP08/21/1981SCS       
AP08/21/1981SLR       
AP012/28/1981SLR       
AP011/21/1983SPD       
AP03/2/1984SCE       
AP07/13/1983SCS       
AP07/13/1983SLR       
AP01/21/1983SCS       
AP05/20/1985SCP       
AP012/1/1983SLR       
AP09/11/1985SLR       
AP08/19/1985SLR       
AP08/24/1985SLR       
AP01/27/1987SCP       
AP01/27/1987SLR       
AP09/15/1987SCS       
AP07/13/1987SLR       
AP04/27/1988SCP       
AP02/6/1991SCS       
AP02/6/1991SCP       
AP08/8/1991SLR       
AP03/11/1999SLR       
AP01/25/1993SCS       
AP03/11/1999SLR       
AP04/9/1997SCM       
AP03/11/1999SLR       
AP03/11/1999SLR       
AP01/31/2001SCS       
AP010/30/2005SLR12986061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016964s061lbl.pdf 11/1/2005
AP010/30/2005SLR12997061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016964s061ltr.pdf 11/1/2005
AP02/19/2010SLR24844069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016964s069ltr.pdf 2/25/2010
AP02/19/2010SLR24860069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016964s069lbl.pdf 2/25/2010
AP01/30/2012SLR31610070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016964s070lbl.pdf 1/30/2012
AP01/30/2012SLR31622070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf 2/1/2012
AP07/30/2013SCM       
AP09/19/2014SCM       
AP012/15/2014SCM       




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