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FDA Drug Application 019922 by HOSPIRA

Application Number019922
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/23/1997N24631000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019922_toc.cfm 1/26/2010
AP01/13/1998SCM       
AP07/6/2000SCM       
AP04/1/2004SE58269005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf 4/5/2004
AP04/1/2004SE58310005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19922se5-005ltr.pdf 4/7/2004
AP012/17/2015SLR44828016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019922Orig1s016ltr.pdf 12/18/2015
AP012/17/2015SLR44830016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf 12/18/2015




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