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FDA Drug Application 022399 by ARBOR PHARMS LLC

Application Number022399
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
AP04/6/2011N28475000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf 4/7/2011
AP04/6/2011N28482000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250398.pdf 4/7/2011
AP04/6/2011N28513000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022399s000ltr.pdf 4/11/2011
AP04/6/2011N28805000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000TOC.cfm 5/16/2011
AP04/6/2011N28806000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000SumR.pdf 5/16/2011
AP06/6/2012SE132855003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s003ltr.pdf 6/8/2012
AP06/6/2012SE132879003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf 6/11/2012
AP04/18/2012SLR32487004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf 4/20/2012
AP04/18/2012SLR32498004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s004ltr.pdf 4/23/2012
AP03/27/2013SE835569005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s005ltr.pdf 3/29/2013
AP03/27/2013SE835609005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf 4/1/2013
AP012/26/2012SLR34780006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf 12/27/2012
AP012/26/2012SLR34793006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf 12/28/2012
AP012/26/2012SLR34779007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf 12/27/2012
AP012/26/2012SLR34794007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf 12/28/2012
AP05/1/2013SLR35950008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s008ltr.pdf 5/7/2013
AP05/1/2013SLR36016008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf 5/9/2013
AP010/29/2013SCM       




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