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FDA Drug Application 200582 by HOSPIRA INC

Application Number200582
Application Type New Drug Application
Sponsor ApplicantHOSPIRA INC
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
AP02/2/2011N27714000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200582s000lbl.pdf 2/4/2011
AP02/2/2011N27758000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200582s000ltr.pdf 2/7/2011
AP02/2/2011N28799000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582_topotecan_toc.cfm 5/13/2011
AP02/2/2011N28800000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582Orig1s000SumR.pdf 5/13/2011
AP02/28/2014SLR38643001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf 3/4/2014
AP02/28/2014SLR38665001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200582Origs001ltr.pdf 3/5/2014
AP01/29/2016SLR45056002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200582Orig1s002ltr.pdf 1/29/2016
AP01/29/2016SLR45273002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf 2/25/2016




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