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FDA Drug Application 011719 by HOSPIRA

Application Number011719
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/10/1959N       
AP07/22/1975SCS       
AP011/3/1975SFP       
AP011/3/1975SLR       
AP012/5/1975SLR       
AP06/29/1976SCM       
AP06/29/1976SLR       
AP08/3/1976SCM       
AP06/29/1976SCS       
AP09/7/1976SCS       
AP09/7/1976SCM       
AP09/7/1976SCS       
AP09/14/1976SCS       
AP09/14/1976SCS       
AP08/2/1977SCM       
AP03/28/1977SCM       
AP03/18/1977SCS       
AP07/14/1977SCM       
AP08/22/1978SCS       
AP01/2/1979SCS       
AP08/8/1978SCM       
AP012/14/1978SCS       
AP02/15/1979SCS       
AP06/11/1980SCM       
AP010/15/1979SCM       
AP02/29/1980SCS       
AP012/3/1980SCE       
AP05/11/1981SCM       
AP012/7/1981SCM       
AP03/31/1982SLR       
AP03/31/1982SCS       
AP04/8/1983SCM       
AP08/24/1982SLR       
AP04/8/1983SCS       
AP03/19/1987SCM       
AP09/16/1986SCM       
AP09/16/1986SLR       
AP08/18/1987SCM       
AP012/8/1986SCM       
AP01/18/1990SLR       
AP04/7/1988SE1       
AP04/7/1988SCS       
AP04/21/1988SCF       
AP03/1/1989SCS       
AP02/20/1991SCS       
AP010/24/1990SCS       
AP011/5/1991SCP       
AP01/23/1992SCM       
AP04/25/1995SCS       
AP05/20/1997SLR       
AP011/8/2000SLR       
AP06/22/1998SCM       
AP02/12/1999SCS       
AP010/29/1999SLR       
AP05/8/2001SLR       
AP02/20/2002SLR4774102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf 2/20/2002
AP02/20/2002SLR3566103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf 2/20/2002
AP01/3/2003SLR3564104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr104ltr.pdf 1/3/2003
AP07/30/2003SLR6416105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf 8/6/2003
AP01/27/2004SLR7650106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf 2/2/2004
AP01/27/2004SLR7654106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf 2/3/2004
AP012/15/2004SCM10869107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf 12/30/2004
AP04/13/2005SCM11435108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf 4/19/2005
AP011/1/2011SLR30480117   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf 11/3/2011
AP011/1/2011SLR30500117   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf 11/4/2011
AP08/14/2015SCM       
AP011/20/2015SLR44564122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf 11/23/2015
AP011/20/2015SLR44590122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf 11/25/2015
AP02/3/2016SCM       




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