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FDA Drug Application 020646 by CEPHALON

Application Number020646
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1997N11417000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107285.htm 4/15/2005
AP09/30/1997N24470000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020646_gabitril_toc.cfm 1/7/2010
AP09/30/1997N26660000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf 10/13/2010
AP010/9/1997SCS       
AP05/8/1998SCP       
AP07/31/1998SCS       
AP04/16/1999SCM       
AP04/16/1999SLR       
AP08/23/1999SCE       
AP05/17/2000SCS       
AP05/16/2000SCM       
AP07/27/2001SCM       
AP010/3/2001SCP       
AP010/3/2001SCM       
AP02/14/2005SLR11130014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s014ltr.pdf 2/17/2005
AP02/14/2005SLR11135014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf 2/17/2005
AP011/29/2005SCM13200015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf 12/5/2005
AP011/29/2005SCM13215015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s015ltr.pdf 12/6/2005
AP04/23/2009SLR22399016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020646s016ltr.pdf 5/4/2009
AP04/23/2009SLR22534016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf 5/12/2009
AP010/11/2010SLR26619017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf 10/11/2010
AP010/11/2010SLR26651017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020646s017ltr.pdf 10/13/2010
AP011/4/2015SLR44428018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020646Orig1s018ltr.pdf 11/9/2015
AP011/4/2015SLR44437018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf 11/12/2015
AP01/25/2012SLR31581020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020646s020ltr.pdf 1/30/2012
AP08/9/2016SLR46761021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020646Orig1s021ltr.pdf 8/10/2016
AP08/9/2016SLR46767021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf 8/10/2016




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