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FDA Drug Application 022331 by CONCORDIA PHARMS INC

Application Number022331
Application Type New Drug Application
Sponsor ApplicantCONCORDIA 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
AP09/29/2009N23548000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022331s000ltr.pdf 10/7/2009
AP09/29/2009N23549000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022331lbl.pdf 10/7/2009
AP09/29/2009N23812000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331_jenloga_toc.cfm 11/10/2009
AP09/28/2010SE126597001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s001,s002ltr.pdf 10/4/2010
AP09/28/2010SE126612001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf 10/7/2010
AP09/28/2010SE126613002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf 10/7/2010
AP09/28/2010SLR26610005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s005lbl.pdf 10/7/2010
AP09/28/2010SLR26596005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s005ltr.pdf 10/4/2010
AP02/12/2013SLR35164012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022331Orig1s012ltr.pdf 2/14/2013
AP02/12/2013SLR35167012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022331s012lbl.pdf 2/14/2013
AP08/16/2016SLR46798013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022331Orig1s013ltr.pdf 8/18/2016
AP08/16/2016SLR46976013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022331s013lbl.pdf 9/6/2016
AP011/20/2014SE841065014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022331Orig1s014ltr.pdf 11/21/2014
AP011/20/2014SE841273014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf 12/16/2014
AP06/5/2015SLR43019015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022331Orig1s015ltr.pdf 6/10/2015
AP06/5/2015SLR43022015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022331s015lbl.pdf 6/10/2015
AP07/20/2016SCM       
AP05/3/2016SCM       
AP09/28/2016SCM       




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