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FDA Drug Application 206494 by CEREXA INC

Application Number206494
Application Type New Drug Application
Sponsor ApplicantCEREXA INC
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
AP02/25/2015N41918000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494Orig1s000ltr.pdf 2/27/2015
AP02/25/2015N41924000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s000lbl.pdf 2/27/2015
AP02/25/2015N42117000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000TOC.cfm 3/12/2015
AP02/25/2015N42118000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000SumR.pdf 3/12/2015
AP09/2/2015SLR43817001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s001lbl.pdf 9/4/2015
AP09/2/2015SLR43823001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494orig1s001ltr.pdf 9/4/2015
AP06/22/2016SE846404002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206494Orig1s002ltr.pdf 6/23/2016
AP06/22/2016SE846408002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206494s002lbl.pdf 6/23/2016




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