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FDA Drug Application 020405 by CONCORDIA PHARMS INC

Application Number020405
Application Type New Drug Application
Sponsor ApplicantCONCORDIA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1997N24946000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020405_lanoxin_toc.cfm 3/3/2010
AP02/19/1999SCP       
AP012/7/2000SCM       
AP02/5/2010SLR24766004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf 2/16/2010
AP02/5/2010SLR24796004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020405s004ltr.pdf 2/17/2010
AP08/13/2012SLR33466005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf 8/15/2012
AP08/13/2012SLR33488005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020405Orig1s005ltr.pdf 8/16/2012
AP011/14/2011SLR30583006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf 11/14/2011
AP011/14/2011SLR30590006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020405s006ltr.pdf 11/16/2011
AP010/17/2013SLR37462007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf 10/18/2013
AP010/17/2013SLR37477007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020405Orig1s007ltr.pdf 10/21/2013
AP05/21/2013SCM       
AP011/22/2013SCM       
AP07/28/2015SLR43513011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020405Orig1s011ltr.pdf 7/29/2015
AP07/28/2015SLR43540011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf 7/30/2015
AP09/3/2015SCM       




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