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FDA Drug Application 022249 by CEPHALON

Application Number022249
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/20/2008N19495000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022249lbl.pdf 3/20/2008
AP03/20/2008N19501000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022249s000ltr.pdf 3/21/2008
AP03/20/2008N19791000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/treanda_022249_TOC.cfm 5/8/2008
AP03/20/2008N19792000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22249s000_SumR.pdf 5/8/2008
AP05/1/2009SCS22446001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s001ltr.pdf 5/6/2009
AP05/1/2009SCS22479001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s001lbl.pdf 5/11/2009
AP04/22/2009SLR22327002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022249s002,022303s000ltr.pdf 4/27/2009
AP04/22/2009SLR22336002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022249s002lbl.pdf 4/28/2009
AP02/26/2010SLR24925005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s005lbl.pdf 3/3/2010
AP02/26/2010SLR24955005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s005ltr.pdf 3/4/2010
AP012/21/2010SLR27381006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf 12/26/2010
AP012/21/2010SLR27397006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022249s006ltr.pdf 12/28/2010
AP06/26/2012SLR33033012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022249s012ltr.pdf 6/27/2012
AP06/26/2012SLR33038012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf 6/27/2012
AP08/28/2013SLR36915014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s014lbl.pdf 8/29/2013
AP08/28/2013SLR36921014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022249Orig1s014ltr.pdf 8/29/2013
AP09/13/2013SCM37107015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022249s015lbl.pdf 9/17/2013
AP09/13/2013SCM40101015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022249Orig1s015.pdf 8/1/2014
AP03/27/2014SCM       
AP07/8/2015SCM       
AP03/10/2015SLR46649019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s019.pdf 7/27/2016
AP03/10/2015SLR42082019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249Orig1s019lbl.pdf 3/10/2015
AP03/10/2015SLR42093019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s019ltr.pdf 3/11/2015
AP011/5/2015SLR44421020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s020ltr.pdf 11/9/2015
AP011/5/2015SLR44445020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s020lbl.pdf 11/12/2015
AP09/2/2015SLR46650021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022249Orig1s021.pdf 7/27/2016
AP09/2/2015SLR43781021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022249s021lbl.pdf 9/2/2015
AP09/2/2015SLR43818021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022249Orig1s021ltr.pdf 9/4/2015
AP010/18/2016SLR47400022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022249s022lbl.pdf 10/19/2016
AP010/18/2016SLR47412022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022249Orig1s022ltr.pdf 10/20/2016




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