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FDA Drug Application 016367 by HOSPIRA

Application Number016367
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
AP02/12/1971N       
AP05/20/1975SCS       
AP05/20/1975SCS       
AP010/29/1975SCS       
AP09/3/1975SCS       
AP04/6/1976SCS       
AP04/6/1976SLR       
AP011/20/1975SCS       
AP011/8/1976SCP       
AP03/1/1976SLR       
AP011/23/1976SCS       
AP010/15/1976SLR       
AP04/29/1977SCM       
AP02/9/1978SCS       
AP03/15/1978SCP       
AP09/9/1977SLR       
AP09/9/1977SLR       
AP09/9/1977SCS       
AP09/9/1977SCS       
AP01/23/1978SCS       
AP07/11/1978SCS       
AP09/28/1977SLR       
AP09/28/1977SLR       
AP02/13/1978SCM       
AP06/5/1978SCS       
AP02/17/1978SLR       
AP05/31/1978SCF       
AP09/13/1978SCS       
AP04/6/1978SLR       
AP08/3/1978SCS       
AP06/5/1978SCS       
AP06/5/1978SLR       
AP02/8/1978SLR       
AP06/26/1978SCS       
AP09/8/1978SCS       
AP08/15/1978SCS       
AP09/8/1978SCS       
AP02/6/1979SCS       
AP03/27/1979SCS       
AP03/27/1979SLR       
AP011/24/1978SCS       
AP09/8/1978SCS       
AP03/27/1979SCS       
AP03/27/1979SLR       
AP01/17/1978SCS       
AP01/17/1978SLR       
AP02/16/1979SCS       
AP010/17/1978SLR       
AP011/1/1978SCS       
AP02/1/1979S       
AP07/17/1979SLR       
AP012/3/1979SCS       
AP011/27/1979SCS       
AP012/3/1979SCS       
AP04/16/1980SCS       
AP04/16/1980SLR       
AP01/22/1980SCS       
AP07/14/1980SCE       
AP011/29/1979SCS       
AP010/10/1979SCS       
AP04/8/1980SLR       
AP07/16/1981SCS       
AP09/15/1980SCS       
AP01/7/1981SCS       
AP03/2/1981SCS       
AP03/2/1981SLR       
AP07/8/1982SPD       
AP03/2/1981SLR       
AP07/31/1981SCS       
AP07/31/1981SLR       
AP09/16/1981SCS       
AP010/21/1981SCS       
AP010/21/1981SLR       
AP010/7/1981SCS       
AP06/9/1982SCS       
AP01/8/1982SCS       
AP02/1/1982SCS       
AP02/22/1982SLR       
AP07/8/1982SCS       
AP02/15/1983SCM       
AP03/1/1984SCS       
AP07/26/1982SCS       
AP010/10/1984SCP       
AP010/10/1984SLR       
AP01/25/1983SCS       
AP06/6/1983SCM       
AP02/17/1984SCS       
AP09/19/1983SCM       
AP012/8/1983SCS       
AP01/17/1983SCE       
AP08/31/1983SCS       
AP03/21/1984SCS       
AP010/17/1984SCS       
AP09/25/1984SCS       
AP06/14/1984SCE       
AP04/9/1984SCS       
AP01/8/1985SCS       
AP01/8/1985SLR       
AP08/31/1988SCS       
AP011/28/1984SCS       
AP010/29/1985SCP       
AP011/29/1985SCS       
AP011/29/1985SLR       
AP09/26/1985SCP       
AP010/22/1984SCS       
AP01/18/1985SCS       
AP01/18/1985SLR       
AP010/26/1985SCS       
AP05/3/1985SCS       
AP010/26/1985SLR       
AP08/27/1985SCE       
AP09/30/1985SCE       
AP011/7/1985SLR       
AP06/10/1985SCS       
AP06/21/1985SCS       
AP01/18/1986SCS       
AP02/21/1986SCS       
AP08/8/1986SCS       
AP011/26/1986SCS       
AP07/30/1987SCS       
AP010/17/1988SCE       
AP08/8/1988SCM       
AP06/14/1989SCS       
AP02/22/1990SCM       
AP01/11/1990SCM       
AP09/10/1991SCS       
AP01/28/1992SCP       
AP08/30/1991SCP       
AP05/24/1994SLR       
AP08/14/1995SCS       
AP08/27/1996SCS       
AP08/29/1996SCS       
AP08/18/1995SCM       
AP03/4/1996SCS       
AP08/6/1996SCS       
AP03/28/1997SCS       
AP08/20/1997SLR       
AP06/11/1997SCM       
AP08/21/1997SCP       
AP010/29/1998SCS       
AP06/4/1999SCS       
AP03/6/2000SLR       
AP03/3/2000SCP       
AP04/3/2002SCM       
AP04/3/2002SCM       
AP011/8/2002SCS       
AP09/2/2005SCP12725178   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf 9/7/2005
AP09/2/2005SCP12726178   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016367s178ltr.pdf 9/7/2005
AP010/26/2006SCP15282182   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf 10/27/2006
AP010/26/2006SCP15288182   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016367s182ltr.pdf 10/31/2006
AP09/5/2013SCM       
AP02/23/2016SCM       




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