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FDA Drug Application 018692 by HOSPIRA

Application Number018692
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
AP05/4/1984N       
AP06/26/1987SCS       
AP03/9/1999SLR       
AP03/9/1999SLR       
AP08/21/2001SCS       
AP06/12/2003SLR5952007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18692slr007ltr.pdf 6/22/2003
AP02/19/2010SLR24845014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018692s014ltr.pdf 2/25/2010
AP02/19/2010SLR24859014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf 2/25/2010
AP01/30/2012SLR31609015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf 1/31/2012
AP01/30/2012SLR31623015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf 2/1/2012
AP09/19/2014SCM       




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