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FDA Drug Application 202331 by ARBOR PHARMS LLC

Application Number202331
Application Type New Drug Application
Sponsor ApplicantARBOR PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2011N31270000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202331s000ltr.pdf 12/27/2011
AP012/20/2011N31490000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202331lbl.pdf 1/24/2012
AP012/20/2011N33484000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331_edarbyclor_toc_.cfm 8/16/2012
AP012/20/2011N33485000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202331Orig1s000SumR.pdf 8/16/2012
AP010/2/2012SLR33963002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202331Orig1s002ltr_replacement.pdf 10/4/2012
AP010/2/2012SLR33986002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202331s002lbl.pdf 10/5/2012
AP04/18/2014SLR39108005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf 4/21/2014
AP07/23/2014SLR39976006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202331s006lbl.pdf 7/24/2014
AP07/23/2014SLR39995006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202331Orig1s006ltr.pdf 7/24/2014
AP04/16/2015SLR42555007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202331Orig1s007ltr.pdf 4/17/2015
AP04/16/2015SLR42556007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202331s007lbl.pdf 4/17/2015
AP011/18/2015SCM       
AP08/29/2016SCM       
AP010/24/2016SLR47441011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202331Orig1s011ltr.pdf 10/26/2016
AP010/24/2016SLR47511011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202331s011lbl.pdf 10/28/2016




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