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FDA Drug Application 020747 by CEPHALON

Application Number020747
Application Type New Drug Application
Sponsor ApplicantCEPHALON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/4/1998N179000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20747ltr.pdf 11/4/1998
AP011/4/1998N180000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20747_Actiq.cfm 7/19/2000
AP011/4/1998N181000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf 11/4/1998
AP011/4/1998N15832000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085817.pdf 2/20/2007
AP011/4/1998N31311000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 12/30/2011
AP03/26/1999SLR       
AP03/26/1999SLR31919003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020747Orig1s003.pdf 2/28/2012
AP08/25/2000SCS       
AP04/9/2001SCS5026006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20747S6ltr.pdf 4/11/2001
AP02/19/2003SCM4698008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20747scm008ltr.pdf 2/19/2003
AP01/29/2003SLR4697009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747slr009ltr.pdf 1/29/2003
AP03/12/2002SLR4696010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s10ltr.pdf 3/7/2002
AP06/10/2002SLR2450011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20747s011ltr.pdf 6/10/2002
AP09/24/2004SLR10297017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20747s017ltr.pdf 9/29/2004
AP09/24/2004SLR10298017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf 9/29/2004
AP01/19/2005SLR11033018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s018ltr.pdf 1/26/2005
AP09/9/2005SCF12785019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020747s019ltr.pdf 9/15/2005
AP09/9/2005SCF12801019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020747s019lbl.pdf 9/15/2005
AP09/9/2005SCF20333019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020747_S019_ACTIQ.pdf 7/30/2008
AP09/6/2006SLR14803023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020747s023lbl.pdf 9/12/2006
AP09/6/2006SLR16209023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020747s023_ltr.pdf 4/11/2007
AP02/7/2007SE515821027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020747s027ltr.pdf 2/12/2007
AP02/7/2007SE515863027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf 2/21/2007
AP07/20/2011SLR29566029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747Orig1s029ltr.pdf 7/21/2011
AP07/20/2011SLR29575029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf 7/21/2011
AP011/9/2009SLR23875030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf 11/13/2009
AP011/9/2009SLR24540030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020747s030ltr.pdf 1/20/2010
AP012/28/2011SLR31303033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s033lbl.pdf 12/28/2011
AP012/28/2011SLR31319033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020747s033ltr.pdf 1/3/2012
AP06/5/2012SLR32848034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020747s034ltr.pdf 6/7/2012
AP06/5/2012SLR32888034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf 6/11/2012
AP011/7/2013SLR37748037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020747Orig1s037ltr.pdf 11/8/2013
AP04/22/2013SCM       
AP04/30/2014SCM       
AP012/24/2014S41448041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020747Orig1s041ltr.pdf 12/30/2014




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