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FDA Drug Application 200327 by CEREXA

Application Number200327
Application Type New Drug Application
Sponsor ApplicantCEREXA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2010N26839000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200327s000lbl.pdf 10/29/2010
AP010/29/2010N26885000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200327s000ltr.pdf 11/3/2010
AP010/29/2010N27275000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000TOC.cfm 12/13/2010
AP010/29/2010N27276000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000SumR.pdf 12/14/2010
AP06/29/2011SLR29368001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf 6/30/2011
AP06/29/2011SLR29410001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s001ltr.pdf 7/6/2011
AP03/11/2011SLR28241003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s003lbl.pdf 3/14/2011
AP03/11/2011SLR28263003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s003ltr.pdf 3/16/2011
AP05/22/2012SLR32758005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327s005ltr.pdf 5/24/2012
AP05/3/2012SCM32627007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s007lbl.pdf 5/7/2012
AP010/23/2012SLR34170008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327Orig1s008ltr.pdf 10/24/2012
AP010/23/2012SLR34171008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s008lbl.pdf 10/24/2012
AP05/29/2013SLR36162009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s009ltr.pdf 5/30/2013
AP05/29/2013SLR36219009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s009lbl.pdf 6/4/2013
AP07/29/2013SCM42233010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s010ltr.pdf 3/23/2015
AP07/29/2013SCM42289010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327Orig1s010lbl.pdf 3/26/2015
AP012/16/2013SLR38078011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s011ltr.pdf 12/17/2013
AP012/16/2013SLR38081011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s011lbl.pdf 12/17/2013
AP02/28/2014SCM       
AP08/31/2015SE843791013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf 9/4/2015
AP08/31/2015SE843792014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf 9/4/2015
AP08/31/2015SE843810014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s013s014s015lbl.pdf 9/4/2015
AP08/31/2015SLR43793015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf 9/4/2015
AP08/31/2015SLR43809015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s015lbl.pdf 9/4/2015
AP05/27/2016SE846195016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf 5/31/2016
AP05/27/2016SE846230016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf 6/1/2016
AP05/27/2016SE846231017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf 6/1/2016
AP05/27/2016SE846194017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf 5/31/2016
AP08/11/2016SCM       




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