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FDA Drug Application 020351 by GE HEALTHCARE

Application Number020351
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
AP03/22/1996N       
AP010/10/1997SLR       
AP010/10/1997SE1       
AP09/8/1998SCS       
AP010/11/2001SCM       
AP011/5/2001SCS       
AP06/5/2002SCS       
AP05/1/2002SCS       
AP012/3/2002SCM9636010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20351scm010ltr.pdf 6/30/2004
AP09/4/2003SCP6650011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351scp011ltr.pdf 9/25/2003
AP012/18/2003SLR7347013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351slr013ltr.pdf 12/23/2003
AP012/18/2003SLR7429013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf 12/29/2003
AP03/24/2004SCP8120016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351scp016ltr.pdf 3/28/2004
AP012/30/2004SLR10920018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351s018ltr.pdf 1/11/2005
AP04/20/2005SCM11495020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s020ltr.pdf 4/28/2005
AP08/25/2005SCP12674021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s021ltr.pdf 8/31/2005
AP09/12/2013SCM       
AP011/20/2013SCM       
AP07/6/2015SLR43289043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf 7/9/2015
AP07/6/2015SLR43308043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf 7/10/2015




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