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FDA Drug Application 008708 by CONCORDIA PHARMS INC

Application Number008708
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
AP01/26/1953N       
AP03/15/1983SLR       
AP05/27/1987SPD       
AP05/25/1984SLR       
AP07/28/1988SCS       
AP03/1/1991SCM       
AP07/12/1991SCS       
AP02/3/1995SCM       
AP03/30/2001SCM       
AP01/15/2003SLR8912022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr022ltr.pdf 6/2/2004
AP012/30/2003SLR7487023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr023ltr.pdf 1/9/2004
AP012/30/2003SLR30821023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/008708Orig1s023.pdf 10/10/2011
AP04/3/2008SLR19629025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008708s025ltr.pdf 4/9/2008
AP04/3/2008SLR19662025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf 4/16/2008
AP04/3/2008SLR31915025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/008708Orig1s025.pdf 2/28/2012




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