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FDA Drug Application 200795 by HOSPIRA INC

Application Number200795
Application Type New Drug Application
Sponsor ApplicantHOSPIRA INC
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
AP08/4/2011N29687000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200795s000lbl.pdf 8/5/2011
AP08/4/2011N29721000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200795s000ltr.pdf 8/8/2011
AP08/4/2011N33073000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795_gemcitabine_toc.cfm 7/6/2012
AP08/4/2011N33075000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795Orig1s000SumR.pdf 7/6/2012
AP012/18/2012SCM       
AP06/20/2013SCM       
AP011/27/2013SCM       
AP09/5/2013SLR37007004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200795s004lbl.pdf 9/9/2013
AP09/5/2013SLR37032004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200795Orig1s004ltr.pdf 9/10/2013
AP05/8/2014SLR39268005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200795s005lbl.pdf 5/12/2014
AP05/8/2014SLR39289005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200795Orig1s005ltr.pdf 5/12/2014
AP04/7/2016SCM       




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