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FDA Drug Application 017693 by GE HEALTHCARE

Application Number017693
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
AP011/15/1976N       
AP07/19/1978SCS       
AP01/19/1978SCM       
AP02/13/1978SLR       
AP01/31/1979SLR       
AP010/20/1978SCM       
AP012/28/1979SCM       
AP06/7/1982SLR       
AP02/9/1983SES       
AP01/10/1984SLR       
AP06/1/1988SCS       
AP06/8/1987SLR       
AP01/31/1986SCM       
AP06/30/1987SCM       
AP02/17/1989SCS       
AP011/16/1990SCS       
AP04/17/1995SCM       
AP04/27/1995SCM       
AP06/11/1993SCM       
AP03/24/1997SCM       
AP07/28/1998SCM       
AP012/13/2013SCM38093025Package Insert  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017693s025PI.pdf 12/17/2013
AP010/14/2014SLR40775026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf 10/15/2014
AP010/14/2014SLR40776026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017693Orig1s026ltr.pdf 10/15/2014
AP01/5/2015SCM       
AP08/7/2015SLR43613029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017693Orig1s029ltr.pdf 8/11/2015
AP08/7/2015SLR43833029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf 9/9/2015




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