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FDA Drug Application 022256 by CYPRESS BIOSCIENCE

Application Number022256
Application Type New Drug Application
Sponsor ApplicantCYPRESS BIOSCIENCE
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
AP01/14/2009N21637000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf 1/14/2009
AP01/14/2009N21639000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf 1/14/2009
AP01/14/2009N21642000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2009/022256s000SumR.pdf 1/15/2009
AP01/14/2009N22100000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022256s000TOC.cfm 3/24/2009
AP01/14/2009N24075000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089121.pdf 11/20/2009
AP04/16/2009SCS22302001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256s001ltr.pdf 4/21/2009
AP04/16/2009SCS22315001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf 4/23/2009
AP02/1/2010SLR24786002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s002ltr.pdf 2/16/2010
AP02/1/2010SLR24832002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf 2/23/2010
AP02/1/2010SLR24760004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf 2/16/2010
AP02/1/2010SLR24789004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s004ltr.pdf 2/16/2010
AP05/17/2010SLR25585006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf 5/18/2010
AP05/17/2010SLR25592006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s006ltr.pdf 5/21/2010
AP04/26/2011SLR28673010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s010ltr.pdf 5/3/2011
AP04/26/2011SLR36699010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022256Orig1s010.pdf 8/6/2013
AP011/8/2011SLR30543011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf 11/9/2011
AP011/8/2011SLR30547011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s011ltr.pdf 11/10/2011
AP010/30/2012SLR34336012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s012ltr.pdf 11/8/2012
AP012/6/2012SLR34569013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf 12/7/2012
AP012/6/2012SLR34592013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s013ltr.pdf 12/11/2012
AP010/30/2013SLR37628014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf 10/31/2013
AP010/30/2013SLR37637014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf 10/31/2013
AP010/30/2013SLR37627015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf 10/31/2013
AP010/30/2013SLR37638015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf 10/31/2013
AP06/25/2013SCM36390016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf 6/26/2013
AP011/25/2013SCM       
AP05/21/2015SCM       
AP01/29/2015SLR41748019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf 1/30/2015
AP01/29/2015SLR41751019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022256Orig1s019ltr.pdf 2/2/2015
AP06/17/2015SCM       
AP09/6/2016SLR46991021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s021ltr.pdf 9/8/2016
AP09/6/2016SLR47000021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf 9/8/2016




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