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FDA Drug Application 022066 by GE HEALTHCARE

Application Number022066
Application Type New Drug Application
Sponsor ApplicantGE HEALTHCARE
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
AP09/5/2007N17778000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf 9/7/2007
AP09/5/2007N17804000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022066s000_ltr.pdf 9/7/2007
AP09/5/2007N17918000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 9/24/2007
AP09/5/2007N20950000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000TOC.cfm 10/3/2008
AP09/5/2007N20951000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000_SumR.pdf 10/3/2008
AP012/20/2010SLR27323002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf 12/20/2010
AP012/20/2010SLR27350002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf 12/22/2010
AP08/27/2013SLR36912004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf 8/28/2013
AP08/27/2013SLR36918004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039,%20022066Orig1s004ltr.pdf 8/29/2013
AP05/14/2014SCM       
AP012/11/2012SLR34608006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf 12/13/2012
AP011/14/2014SLR41012007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf 11/18/2014
AP011/14/2014SLR41039007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf 11/20/2014




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