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FDA Drug Application 021287 by CONCORDIA PHARMS INC

Application Number021287
Application Type New Drug Application
Sponsor ApplicantCONCORDIA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/12/2003N5975000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287ltr.pdf 6/22/2003
AP06/12/2003N5987000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf 6/22/2003
AP06/12/2003N6624000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_uroxatral_toc.cfm 9/9/2003
AP07/15/2003SLR6165001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287slr001ltr.pdf 7/28/2003
AP07/15/2003SLR15642001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_S001_UROXATRALTOC.cfml 1/10/2007
AP03/17/2006SLR13775005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf 3/22/2006
AP03/17/2006SLR13799005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s005ltr.pdf 3/23/2006
AP011/16/2006SLR15378007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf 11/22/2006
AP011/16/2006SLR15390007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s007ltr.pdf 11/22/2006
AP03/29/2007SLR16123008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf 3/31/2007
AP03/29/2007SLR16178008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021287s008ltr.pdf 4/9/2007
AP05/6/2008SLR19798009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s009ltr.pdf 5/9/2008
AP09/18/2008SLR20865011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf 9/19/2008
AP09/18/2008SLR20873011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s011ltr.pdf 9/23/2008
AP05/20/2009SLR22613013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf 5/25/2009
AP05/20/2009SLR22630013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021287s013ltr.pdf 5/27/2009
AP04/9/2010SLR25258014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s014ltr.pdf 4/13/2010
AP04/9/2010SLR25303014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf 4/19/2010
AP012/15/2010SE827295016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf 12/16/2010
AP012/15/2010SE827306016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s016ltr.pdf 12/21/2010
AP05/30/2013SLR36167017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021287Orig1s017ltr.pdf 5/31/2013
AP05/30/2013SLR36213017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf 6/4/2013
AP04/21/2014SLR39120018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf 4/22/2014
AP04/21/2014SLR40170018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021287Orig1s018ltr.pdf 8/6/2014
AP03/23/2016SCM       
AP010/18/2016SCM       




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