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FDA Drug Application 021956 by CONCORDIA PHARMS INC

Application Number021956
Application Type New Drug Application
Sponsor ApplicantCONCORDIA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/2006N14770000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021956lbl.pdf 8/29/2006
AP08/28/2006N14866000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021956s000ltr.pdf 9/18/2006
AP08/28/2006N19776000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021956s000TOC.cfm 5/7/2008
AP03/2/2011SLR28111001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf 3/7/2011
AP03/2/2011SLR28122001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf 3/7/2011
AP03/2/2011SLR28123002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf 3/7/2011
AP03/2/2011SLR28112002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf 3/7/2011
AP012/19/2011SLR31067003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s003lbl.pdf 12/19/2011
AP012/19/2011SLR31223003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s003ltr.pdf 12/22/2011
AP010/20/2014SLR40841004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021956s004lbl.pdf 10/21/2014
AP010/20/2014SLR40859004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021956Orig1s004ltr.pdf 10/22/2014
AP012/2/2014SCM       
AP06/6/2016SCM       
AP010/17/2016SCM       




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