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FDA Drug Application 203137 by GE HEALTHCARE

Application Number203137
Application Type New Drug Application
Sponsor ApplicantGE HEALTHCARE
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
AP010/25/2013N37613000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203137Orig1s000ltr.pdf 10/29/2013
AP010/25/2013N37651000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf 10/31/2013
AP010/25/2013N37820000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203137_vizamyl_toc.cfm 11/15/2013
AP02/3/2015SCM       
AP012/4/2014SLR41164002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203137Orig1s002ltr.pdf 12/5/2014
AP012/4/2014SLR41199002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf 12/10/2014
AP06/7/2016SCM       
AP09/29/2016SCM       
AP04/7/2016SLR45624005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf 4/8/2016
AP04/7/2016SLR45630005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203137Orig1s005ltr.pdf 4/11/2016




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