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FDA Drug Application 009768 by CONCORDIA PHARMS INC

Application Number009768
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
AP04/18/1955N       
AP04/29/1976SLR       
AP02/19/1980SLR       
AP05/15/1981SCP       
AP01/2/1987SPD       
AP05/14/1982SCS       
AP06/30/1982SCS       
AP09/15/1982SCS       
AP06/17/1983SCS       
AP011/1/1984SCS       
AP03/3/1987SLR       
AP07/5/1985SCS       
AP07/22/1985SCM       
AP012/12/1986SCM       
AP08/4/1988SCS       
AP09/30/1988SCS       
AP04/4/1989SCS       
AP011/19/1990SCP       
AP02/14/1991SCS       
AP02/14/1991SCS       
AP05/26/1994SLR       
AP010/2/1996SCS       
AP010/5/2000SLR       
AP02/7/2002SCM       
AP05/2/2002SCM       
AP06/20/2007SLR16840041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf 6/27/2007
AP06/20/2007SLR16908041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009768s041ltr.pdf 7/5/2007




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