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FDA Drug Application 020733 by INDIVIOR INC

Application Number020733
Application Type New Drug Application
Sponsor ApplicantINDIVIOR INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/2002N3320000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf 10/8/2002
AP010/8/2002N3321000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf 10/8/2002
AP010/8/2002N10645000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm 11/22/2004
AP010/8/2002N15070000   http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm 10/11/2006
AP010/8/2002N31350000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=315 1/5/2012
AP010/4/2006SLR15099003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf 10/13/2006
AP012/22/2011SLR31256007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf 12/23/2011
AP012/22/2011SLR31258007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008mg.pdf 12/23/2011
AP012/22/2011SLR31317007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf 1/3/2012
AP012/22/2011SLR31318008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf 1/3/2012
AP012/22/2011SLR31259008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008mg.pdf 12/23/2011
AP012/22/2011SLR31257008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf 12/23/2011
AP08/8/2013SCM       
AP010/23/2013SCM       
AP012/11/2014SLR41234014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020733Orig1s014ltr.pdf 12/12/2014
AP012/11/2014SLR41310014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020733Orig1s014lbl.pdf 12/18/2014
AP09/22/2015S43982016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf 9/24/2015
AP07/7/2016S46499017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf 7/12/2016




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