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FDA Drug Application 020134 by GE HEALTHCARE

Application Number020134
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/18/1993N       
AP010/10/1997SCS       
AP012/20/1995SCP       
AP01/7/1997SCP       
AP08/30/1996SCS       
AP08/24/1999SCP       
AP04/3/2013SCM       
AP012/20/2013SLR38140012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020134s012lbl.pdf 12/23/2013
AP012/20/2013SLR38153012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020134Orig1s012ltr.pdf 12/24/2013




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