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FDA Drug Application 021248 by CEPHALON

Application Number021248
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
AP09/25/2000N1527000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21248ltr.pdf 9/25/2000
AP09/25/2000N1528000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf 9/25/2000
AP09/25/2000N4097000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-248_Trisenox.cfm 7/12/2001
AP06/13/2001SCE       
AP01/7/2003SCM       
AP07/23/2010SLR26029008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf 7/28/2010
AP07/23/2010SLR26050008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf 7/30/2010
AP07/23/2010SLR26030009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf 7/28/2010
AP07/23/2010SLR26051009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf 7/30/2010
AP02/20/2015SLR41892013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021248s013lbl.pdf 2/23/2015
AP02/20/2015SLR41898013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021248Orig1s013ltr.pdf 2/24/2015




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