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FDA Drug Application 020649 by AUXILIUM PHARMS INC

Application Number020649
Application Type New Drug Application
Sponsor ApplicantAUXILIUM PHARMS INC
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
AP06/12/1997N6445000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020649_edex_toc.cfm 8/8/2003
AP011/5/1997SCS       
AP07/30/1998SCS       
AP04/1/1998SCM       
AP09/22/1998SCE       
AP010/20/1999SCS       
AP011/19/1999SCF       
AP010/20/1999SCM       
AP010/15/1999SCM       
AP09/6/1999SLR       
AP03/10/2000SCS       
AP07/31/2000SCS       
AP06/1/2000SCE       
AP012/14/2001SCM       
AP06/9/2006SLR14291015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020649s015LTR.pdf 6/12/2006
AP06/9/2006SLR14298015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf 6/12/2006
AP02/11/2014SCM       
AP03/12/2014SCM       
AP03/9/2015SLR42088023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020649Orig1s023ltr.pdf 3/11/2015
AP03/9/2015SLR42299023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf 3/26/2015




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