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FDA Drug Application 021947 by CEPHALON

Application Number021947
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
AP09/25/2006N14983000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021947lbl.pdf 9/26/2006
AP09/25/2006N15041000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021947s000ltr.pdf 10/2/2006
AP09/25/2006N15837000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088597.pdf 2/20/2007
AP09/25/2006N18008000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113690.htm 9/26/2007
AP09/25/2006N18622000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021947s000FentoraTOC.cfm 12/6/2007
AP09/25/2006N31310000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 12/30/2011
AP04/27/2007SLR16335001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s001lbl.pdf 5/1/2007
AP04/27/2007SLR16370001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s001ltr.pdf 5/1/2007
AP03/2/2007SCS15968002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021947s002ltr.pdf 3/7/2007
AP03/2/2007SCS15984002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf 3/7/2007
AP02/7/2008SLR19087006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021947s006ltr.pdf 2/14/2008
AP02/7/2008SLR19112006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021947s006lbl.pdf 2/14/2008
AP02/21/2013SE335230008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s008ltr.pdf 2/25/2013
AP02/21/2013SE335260008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021947s008lbl.pdf 2/26/2013
AP07/20/2011SLR29571009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947Orig1s009ltr.pdf 7/21/2011
AP07/20/2011SLR29574009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s009lbl.pdf 7/21/2011
AP012/2/2009SLR24270010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021947s010lbl.pdf 12/11/2009
AP012/2/2009SLR24614010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021947s010ltr.pdf 1/25/2010
AP01/20/2011SLR27577011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s011lbl.pdf 1/24/2011
AP01/20/2011SLR27597011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s011ltr.pdf 1/25/2011
AP012/28/2011SLR31302013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021947s013lbl.pdf 12/28/2011
AP012/28/2011SLR31325013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021947s013ltr.pdf 1/3/2012
AP05/19/2016SCM       
AP06/5/2012SLR32849015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021947s015ltr.pdf 6/7/2012
AP06/5/2012SLR32887015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf 6/11/2012
AP011/7/2013S37789017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021947Orig1s017ltr.pdf 11/12/2013
AP08/29/2014SCM       
AP012/24/2014S41449022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021947Orig1s022ltr.pdf 12/30/2014




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