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FDA Drug Application 022418 by ARALEZ PHARMS INC

Application Number022418
Application Type New Drug Application
Sponsor ApplicantARALEZ PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/14/2009N23218000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022418s000ltr.pdf 8/21/2009
AP08/14/2009N23517000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022418lbl.pdf 10/1/2009
AP08/14/2009N24420000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418_fibricor_toc.cfm 1/5/2010
AP08/14/2009N24421000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418s000_SumR.pdf 1/5/2010
AP01/3/2012SLR31364006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s006lbl.pdf 1/6/2012
AP01/3/2012SLR31395006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s006ltr.pdf 1/17/2012
AP03/15/2012SLR32137007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s007lbl.pdf 3/16/2012
AP03/15/2012SLR32152007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s007ltr.pdf 3/19/2012
AP012/12/2012SLR34622008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf 12/13/2012
AP012/12/2012SLR34696008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf 12/19/2012
AP012/12/2012SLR34697009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf 12/19/2012
AP012/12/2012SLR34623009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf 12/13/2012
AP03/11/2013SLR35415010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022418s010lbl.pdf 3/11/2013
AP03/11/2013SLR35474010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022418Orig1s010ltr.pdf 3/19/2013
AP01/6/2014SLR38220011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022418Orig1s011ltr.pdf 1/7/2014
AP01/6/2014SLR38227011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022418s011lbl.pdf 1/7/2014
AP011/27/2015SCM       




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