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FDA Drug Application 202714 by ONYX THERAP

Application Number202714
Application Type New Drug Application
Sponsor ApplicantONYX THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/20/2012N33248000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf 7/20/2012
AP07/20/2012N33249000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf 7/20/2012
AP07/20/2012N33529000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000TOC.cfm 8/20/2012
AP07/20/2012N33530000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000SumR.pdf 8/20/2012
AP02/21/2013SCM       
AP04/19/2013SCM       
AP01/31/2014SCM       
AP06/2/2014SCM       
AP011/3/2014SCM       
AP04/21/2015SCM       
AP04/24/2015SCM       
AP03/27/2015SLR42409008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s008ltr.pdf 4/3/2015
AP03/27/2015SLR42469008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf 4/7/2015
AP07/24/2015SE843473009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf 7/24/2015
AP07/24/2015SE843498009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s009ltr.pdf 7/27/2015
AP01/21/2016SE845001010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf 1/22/2016
AP01/21/2016SE845025010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf 1/26/2016
AP05/23/2016SLR46144011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf 5/25/2016
AP05/23/2016SLR46151011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s011ltr.pdf 5/25/2016
AP06/3/2016SLR46466012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf 7/6/2016
AP06/3/2016SLR46467012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714s012ltr.pdf 7/6/2016
AP08/4/2016SLR46728013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s013ltr.pdf 8/5/2016
AP08/4/2016SLR46747013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf 8/9/2016




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