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FDA Drug Application 020372 by GE HEALTHCARE

Application Number020372
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
AP02/9/1996N       
AP012/7/1998SCM       
AP012/9/1998SCM       
AP011/23/2001SE13660003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_Approv.pdf 11/3/2001
AP011/23/2001SE13661003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf 11/3/2001
AP011/23/2001SE13662003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview.cfm 3/12/2002
AP011/12/1999SCS       
AP04/13/2000SCE       
AP04/12/2000SCM       
AP09/29/2000SCM       
AP04/10/2001SCM       
AP08/27/2001SCM5408009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf 4/22/2003
AP012/4/2001SCM       
AP05/22/2002SCM3659011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20372scm011ltr.pdf 5/22/2002
AP011/25/2002SCS       
AP02/28/2003SE16105013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-372s013_Myoview.cfm 7/8/2003
AP02/28/2003SE14075013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf 3/5/2003
AP02/28/2003SE14242013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372se1-013ltr.pdf 3/10/2003
AP011/13/2003SLR6985015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372slr015ltr.pdf 11/26/2003
AP011/13/2003SLR7001015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf 12/1/2003
AP07/7/2005SCF11988019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf 7/15/2005
AP07/7/2005SCF11996019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020372s019ltr.pdf 7/15/2005
AP02/26/2009SCF21958022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020372s022ltr.pdf 3/5/2009
AP02/26/2009SCF22038022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf 3/17/2009
AP03/8/2013SCM       




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