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FDA Drug Application 012342 by CONCORDIA PHARMS INC

Application Number012342
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
AP02/21/1961N24047000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088674.pdf 11/20/2009
AP02/21/1961N16532000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP06/20/1978SLR       
AP05/20/1980SLR       
AP04/6/1981SLR       
AP03/22/1984SE1       
AP03/22/1984SES       
AP02/24/1988SLR       
AP03/15/2001SLR13037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR14039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR16040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR74044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR22046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR30048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP03/15/2001SLR276051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF 3/15/2001
AP07/14/1997SCM       
AP010/23/2001SLR       
AP01/12/2005SLR10958055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12342s055ltr.pdf 1/13/2005
AP01/12/2005SLR10982055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf 1/13/2005
AP01/23/2006SLR13520056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf 1/30/2006
AP01/23/2006SLR13521057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf 1/30/2006
AP08/2/2007SLR17488059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012342s059lbl.pdf 8/3/2007
AP08/2/2007SLR17600059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf 8/7/2007
AP011/27/2009SLR24165061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf 12/2/2009
AP05/14/2010SLR25587063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012342s063ltr.pdf 5/21/2010
AP05/14/2010SLR25641063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012342s063lbl.pdf 5/28/2010




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