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FDA Drug Application 019829 by GE HEALTHCARE

Application Number019829
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
AP012/30/1988N       
AP03/2/1993SCM       
AP04/7/1995SCS       
AP04/7/1995SE1       
AP04/7/1995SCE       
AP07/25/1994SCS       
AP011/27/1996SCP       
AP011/12/1999SCS       
AP09/29/2000SCM       
AP04/10/2001SCM       
AP08/17/2001SCM       
AP011/25/2002SCS       
AP06/15/2005SLR11846019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019829s019ltr.pdf 6/21/2005
AP03/8/2013SCM       
AP08/5/2013SLR36703026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf 8/5/2013
AP08/5/2013SLR36714026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019829Orig1s026ltr.pdf 8/6/2013
AP06/27/2014SCM       
AP04/8/2016SCM       
AP010/5/2016SCM       




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