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FDA Drug Application 021875 by CEPHALON

Application Number021875
Application Type New Drug Application
Sponsor ApplicantCEPHALON
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
AP06/15/2007N16830000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf 6/27/2007
AP06/15/2007N16929000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf 7/5/2007
AP06/15/2007N21959000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.cfm 3/5/2009
AP06/15/2007N36608000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231717.pdf 7/26/2013
AP010/21/2010SLR26738005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf 10/25/2010
AP010/21/2010SLR26750005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf 10/25/2010
AP010/21/2010SLR26753005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015MedGuide.pdf 10/25/2010
AP03/26/2009SCF22148006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf 4/1/2009
AP010/21/2010SLR26739008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf 10/25/2010
AP010/21/2010SLR26751008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf 10/25/2010
AP010/21/2010SLR26754008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015MedGuide.pdf 10/25/2010
AP06/28/2013SLR36405012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf 7/2/2013
AP06/28/2013SLR36560012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf 7/15/2013
AP010/21/2010SLR26740015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf 10/25/2010
AP010/21/2010SLR26752015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf 10/25/2010
AP010/21/2010SLR26755015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015MedGuide.pdf 10/25/2010
AP01/13/2012SLR31410016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf 1/19/2012
AP01/13/2012SLR31411017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf 1/19/2012
AP04/5/2013SCM       
AP08/23/2013SCM       
AP02/9/2015SCM       
AP04/15/2015SLR42543021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf 4/16/2015
AP04/15/2015SLR42552021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf 4/17/2015




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