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FDA Drug Application 020309 by HOSPIRA

Application Number020309
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
AP06/24/1994N27868000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020309_original_approval.pdf 2/15/2011
AP01/18/1995SCP       
AP08/27/1996SCM       
AP08/29/1996SCS       
AP03/28/1996SCP       
AP010/23/1995SLR       
AP04/21/1997SLR       
AP07/14/1997SCS       
AP010/28/1998SLR       
AP010/22/1998SCP       
AP011/6/2002SCP       
AP01/26/2007SCF15776015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020309s015ltr.pdf 2/12/2007
AP011/7/2013SCM       
AP05/29/2013SLR36158028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020309Orig1s028ltr.pdf 5/30/2013
AP05/29/2013SLR36218028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020309s028lbl.pdf 6/4/2013
AP011/26/2014SCM       




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