Back to FDA Applications sponsored by HOSPIRA

FDA Drug Application 050609 by HOSPIRA

Application Number050609
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/24/1986N       
AP09/21/1987SLR       
AP012/5/1991SCG       
AP08/24/1994SLR       
AP08/24/1994SLR       
AP03/12/1993SLR       
AP03/18/1996SCP       
AP010/27/1997SCP       
AP011/8/1999SCS       
AP05/23/2002SLR1799015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf 5/23/2002
AP03/20/2001SCS       
AP08/29/2002SCS       
AP012/13/2002SCE       
AP09/16/2004SLR10228019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50609s019,50182s125ltr.pdf 9/17/2004
AP02/26/2008SLR19323025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050609s025lbl.pdf 2/28/2008
AP02/26/2008SLR19340025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050609s025ltr.pdf 2/29/2008
AP06/9/2011SLR29115032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050609s032ltr.pdf 6/13/2011
AP06/9/2011SLR29184032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050609s032lbl.pdf 6/16/2011
AP02/2/2012SLR31656033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050609s033ltr.pdf 2/6/2012
AP02/2/2012SLR31680033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050609s033lbl.pdf 2/6/2012
AP08/19/2013SLR36861034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050609s034lbl.pdf 8/21/2013
AP08/19/2013SLR36865034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050609Orig1s034ltr.pdf 8/22/2013
AP04/22/2015SCM       
AP010/27/2015SCM       




Back to FDA Applications sponsored by HOSPIRA

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.