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FDA Drug Application 021543 by AUXILIUM PHARMS INC

Application Number021543
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
AP06/19/2003N10470000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-543_Striant.cfm 10/26/2004
AP06/19/2003N5978000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543ltr.pdf 6/22/2003
AP06/19/2003N5984000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21543_striant_lbl.pdf 6/22/2003
AP011/3/2003SLR6995001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543slr001ltr.pdf 11/28/2003
AP011/5/2004SCS10553002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21543s002ltr.pdf 11/8/2004
AP011/5/2004SCS10567002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21543s002lbl.pdf 11/8/2004
AP03/21/2014SLR38878009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s009ltr.pdf 3/25/2014
AP03/21/2014SLR38895009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s009lbl.pdf 3/25/2014
AP06/19/2014SLR39602010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s010ltr.pdf 6/23/2014
AP06/19/2014SLR39645010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s010lbl.pdf 6/23/2014
AP05/11/2015SLR42786011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021543Orig1s011ltr.pdf 5/13/2015
AP05/11/2015SLR42812011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021543s011lbl.pdf 5/13/2015
AP010/25/2016SLR47477012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021543Orig1s012ltr.pdf 10/27/2016




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