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FDA Drug Application 011287 by CONCORDIA PHARMS INC

Application Number011287
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/5/1958N       
AP08/22/1977SLR       
AP08/30/1977SLR       
AP010/5/1979SDS       
AP07/17/1980SLR       
AP08/6/1982SCS       
AP05/7/1991SPD       
AP02/8/1985SCP       
AP09/24/1984SLR       
AP08/25/1987SCM       
AP010/25/1988SCM       
AP010/21/1991SLR       
AP05/9/2003SLR5784017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr017ltr.pdf 6/8/2003
AP012/5/2003SLR7148018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr018ltr.pdf 12/11/2003
AP04/24/2009SLR22412021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s021ltr.pdf 5/4/2009
AP04/24/2009SLR22561021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf 5/13/2009
AP09/2/2009SLR23521022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf 10/1/2009
AP09/2/2009SLR23958022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s022ltr.pdf 11/19/2009
AP01/3/2011SLR27426023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf 1/3/2011
AP01/3/2011SLR27452023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011287s023ltr.pdf 1/5/2011
AP01/13/2014SCM       




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