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FDA Drug Application 020899 by GE HEALTHCARE

Application Number020899
Application Type New Drug Application
Sponsor ApplicantGE HEALTHCARE
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
AP012/31/1997N20187000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110260.htm 7/11/2008
AP07/31/1998SCM       
AP02/1/1999SCM       
AP03/14/2000SLR       
AP02/4/2000SCM       
AP05/6/1999SCM       
AP012/18/2000SCM       
AP05/10/2002SCM2681007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20899scm007ltr.pdf 5/10/2002
AP05/10/2002SCM18181007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf 10/4/2007
AP011/8/2007SLR18456010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020899s010ltr.pdf 11/19/2007
AP06/6/2008SLR19967011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020899s011ltr.pdf 6/9/2008
AP06/6/2008SLR19997011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020899s011lbl.pdf 6/12/2008
AP08/17/2012SE833520015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020899Orig1s015ltr.pdf 8/20/2012
AP08/17/2012SE833528015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020899s015lbl.pdf 8/20/2012
AP011/15/2013SCM       
AP04/15/2016SCM       
AP09/16/2016SLR47115018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf 9/20/2016
AP09/16/2016SLR47101018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf 9/20/2016
AP09/16/2016SLR47102019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf 9/20/2016
AP09/16/2016SLR47116019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf 9/20/2016




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