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FDA Drug Application 020123 by GE HEALTHCARE

Application Number020123
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
AP01/8/1993N14263000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP04/26/1993SCS       
AP011/4/1994SCM       
AP06/6/1994SCM       
AP02/5/1996SE2       
AP02/5/1996SE1       
AP02/5/1996SE2       
AP02/17/1995SCS       
AP03/27/1997SCM       
AP03/19/1997SCS       
AP010/3/1997SLR4316015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020123_s015.pdf 10/3/1997
AP01/17/2001SCE       
AP03/13/2001SCM       
AP07/8/2002SLR2902018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s018ltr.pdf 7/8/2002
AP07/30/2001SCS       
AP03/15/2002SCM       
AP05/20/2002SCM2901021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s021ltr.pdf 5/17/2002
AP06/28/2002SLR2900022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s022ltr.pdf 6/28/2002
AP011/15/2002SCM6282023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123scm023ltr.pdf 7/31/2003
AP08/12/2002SCS       
AP09/5/2007SLR17757034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s034lbl.pdf 9/6/2007
AP09/5/2007SLR17803034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s034_ltr.pdf 9/7/2007
AP012/14/2007SLR18692035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf 12/27/2007
AP012/14/2007SLR18841035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s035ltr.pdf 1/9/2008
AP012/20/2010SLR27322037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf 12/20/2010
AP012/20/2010SLR27349037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf 12/22/2010
AP08/27/2013SLR36913039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf 8/28/2013
AP08/27/2013SLR36917039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039, 022066Orig1s004ltr.pdf 8/29/2013
AP05/14/2014SCM       
AP04/3/2014SCM       
AP06/23/2014SCM       
AP011/14/2014SLR41011043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf 11/18/2014
AP011/14/2014SLR41040043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf 11/20/2014
AP06/6/2016SCM       




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