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FDA Drug Application 020717 by CEPHALON

Application Number020717
Application Type New Drug Application
Sponsor ApplicantCEPHALON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1998N154000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20717ltr.pdf 12/24/1998
AP012/24/1998N155000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020717A_Provigil.cfm 12/24/1998
AP012/24/1998N156000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf 12/24/1998
AP012/14/1999SCS16220001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020717_S001_PROVIGIL_TABS_AP.pdf 4/11/2007
AP05/17/2000SCM16221002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S002_PROVIGIL_TABS_AP.pdf 4/11/2007
AP09/19/2000SCS16222003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S003_PROVIGIL_TABS_AP.pdf 4/11/2007
AP011/5/2001SCM16223004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020717_S004_PROVIGIL_TABS_AP.pdf 4/11/2007
AP04/16/2003SCP5695006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scp006ltr.pdf 5/29/2003
AP04/16/2003SCP17933006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S006_PROVIGIL_TABS.pdf 9/24/2007
AP01/23/2004SE17641008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20717se1-008ltr.pdf 2/2/2004
AP01/23/2004SE17660008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-008_provigil_lbl.pdf 2/3/2004
AP07/29/2003SCF6514009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scf009ltr.pdf 8/15/2003
AP07/29/2003SCF17932009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S009_PROVIGIL_TABS.pdf 9/24/2007
AP011/10/2003SCM       
AP06/22/2004SCS       
AP04/6/2004SCP       
AP08/17/2007S17661013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf 8/21/2007
AP010/27/2004SCM       
AP01/26/2005SCS       
AP03/8/2005SCM       
AP03/8/2006SCM       
AP08/17/2007S17662018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf 8/21/2007
AP18/17/2007SLR17664020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf 8/21/2007
AP18/17/2007SLR17686020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020717s020ltr.pdf 8/22/2007
AP08/7/2006SCM       
AP012/13/2006SCM       
AP06/15/2007SCM       
AP010/21/2010SLR26735030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf 10/25/2010
AP010/21/2010SLR26741030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf 10/25/2010
AP010/21/2010SLR26744030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf 10/25/2010
AP010/21/2010SLR26736034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf 10/25/2010
AP010/21/2010SLR26742034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf 10/25/2010
AP010/21/2010SLR26745034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf 10/25/2010
AP010/21/2010SLR26737036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf 10/25/2010
AP010/21/2010SLR26743036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf 10/25/2010
AP010/21/2010SLR26746036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf 10/25/2010
AP01/15/2015SLR41641037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf 1/20/2015
AP01/15/2015SLR41650037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf 1/20/2015
AP01/15/2015SLR41640038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf 1/20/2015
AP01/15/2015SLR41651038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf 1/20/2015
AP01/13/2012SLR31408040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf 1/19/2012
AP01/13/2012SLR31409041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf 1/19/2012
AP04/24/2014SCM       




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