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FDA Drug Application 018511 by DRAXIMAGE

Application Number018511
Application Type New Drug Application
Sponsor ApplicantDRAXIMAGE
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
AP012/29/1989N       
AP09/7/1990SLR       
AP03/30/1994SCM       
AP08/9/1994SCS       
AP08/23/1996SLR       
AP04/2/1999SLR       
AP04/2/1999SLR       
AP012/10/2001SCM       
AP09/23/2011SLR30106019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018511s019ltr.pdf 9/28/2011
AP09/23/2011SLR30129019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf 9/29/2011
AP03/28/2014SCM       
AP010/27/2014SCM       
AP01/5/2015SCM       




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