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FDA Drug Application 125338 by AUXILIUM PHARMS

Application Number125338
Application Type Biologic License Application
Sponsor ApplicantAUXILIUM PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/2/2010N247550000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf 2/16/2010
AP02/2/2010N247570000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338s000MG.pdf 2/16/2010
AP02/2/2010N248140000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf 2/18/2010
AP02/2/2010N250780000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000TOC.cfm 3/19/2010
AP02/2/2010N250790000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000SumR.pdf 3/19/2010
AP02/2/2010N252660000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=71 4/15/2010
AP02/24/2012SLR319110040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125338s0040ltr.pdf 2/27/2012
AP02/24/2012SLR319230040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf 2/28/2012
AP02/24/2012SLR319240040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040mg.pdf 2/28/2012
AP012/6/2013SE8379930061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125338Orig1s0061ltr.pdf 12/10/2013
AP012/6/2013SE8380130061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf 12/12/2013
AP010/20/2014SE840842084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf 10/21/2014
AP010/20/2014SE840858084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125338Orig1s084ltr.pdf 10/22/2014
AP05/15/2015SE842839085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf 5/20/2015
AP05/15/2015SE842868085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf 5/21/2015
AP05/15/2015SE842840087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf 5/20/2015
AP05/15/2015SE842867087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf 5/21/2015
AP05/15/2015SE842841088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf 5/20/2015
AP05/15/2015SE842869088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf 5/21/2015
AP09/19/2016SLR47125102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf 9/20/2016
AP09/19/2016SLR47134102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s102ltr.pdf 9/21/2016




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