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FDA Drug Application 021454 by AUXILIUM PHARMS

Application Number021454
Application Type New Drug Application
Sponsor ApplicantAUXILIUM PHARMS
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
AP010/31/2002N23709000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188475.pdf 10/30/2009
AP010/31/2002N3932000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21454ltr.pdf 10/31/2002
AP010/31/2002N3933000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf 10/31/2002
AP010/31/2002N10951000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-454_Testim.cfm 1/11/2005
AP010/31/2002N43258000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=56 7/7/2015
AP09/18/2009SLR23514008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf 10/1/2009
AP09/18/2009SLR23685008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021454s008ltr.pdf 10/26/2009
AP011/22/2011SLR30778014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021454s014ltr.pdf 11/28/2011
AP011/22/2011SLR30812014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf 11/30/2011
AP011/22/2011SLR30813014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014mg.pdf 11/30/2011
AP08/30/2013SLR36940016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021454Orig1s016ltr.pdf 9/4/2013
AP08/30/2013SLR37017016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf 9/9/2013
AP01/2/2014SCM       
AP05/1/2014S39221020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s020ltr.pdf 5/6/2014
AP06/19/2014SLR39610021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s021ltr.pdf 6/23/2014
AP06/19/2014SLR39628021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf 6/23/2014
AP04/9/2015SCM       
AP05/11/2015SLR42784023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021454Orig1s023ltr.pdf 5/12/2015
AP05/11/2015SLR42813023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf 5/13/2015
AP010/25/2016SLR47475024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021454Orig1s024ltr.pdf 10/27/2016




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