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FDA Drug Application 200796 by ARBOR PHARMS LLC

Application Number200796
Application Type New Drug Application
Sponsor ApplicantARBOR PHARMS LLC
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
AP02/25/2011N28005000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s000ltr.pdf 3/2/2011
AP02/25/2011N28058000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf 3/4/2011
AP02/25/2011N28455000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200796sOrig1s000_Edarbi_TOC.cfm 4/4/2011
AP04/12/2011SLR28548001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s001ltr.pdf 4/15/2011
AP04/12/2011SLR28554001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf 4/15/2011
AP012/14/2011SLR30984002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf 12/14/2011
AP012/14/2011SLR30998002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s002ltr.pdf 12/15/2011
AP010/4/2012SLR33962003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200796Orig1s003ltr_replacement.pdf 10/4/2012
AP010/4/2012SLR33985003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf 10/5/2012
AP07/29/2013SCM       
AP04/18/2014SLR39107005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf 4/21/2014
AP07/23/2014SLR39975006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf 7/24/2014
AP07/23/2014SLR40113006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s006ltr.pdf 8/4/2014
AP03/24/2016SCM       
AP09/29/2016SCM       
AP010/24/2016SLR47442009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200796Orig1s009ltr.pdf 10/26/2016
AP010/24/2016SLR47510009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200796s009lbl.pdf 10/28/2016




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