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FDA Drug Application 017881 by DRAXIMAGE

Application Number017881
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
AP012/30/1987N       
AP07/17/1989SLR       
AP04/2/1999SLR       
AP04/2/1999SLR       
AP07/23/2002SCM3531004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17881scm004ltr.pdf 7/23/2002
AP010/17/2008SLR21030009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017881s009ltr.pdf 10/21/2008
AP06/5/2009SCS22735010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf 6/10/2009
AP06/5/2009SCS22747010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017881s010ltr.pdf 6/16/2009
AP09/23/2011SLR30102016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017881s016ltr.pdf 9/28/2011
AP09/23/2011SLR30128016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf 9/29/2011
AP03/4/2013SCM       
AP05/11/2015SCM       
AP03/1/2016SCM       
AP06/9/2016SCM46286025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017881Orig1s025ltr.pdf 6/10/2016




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