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FDA Drug Application 020732 by INDIVIOR INC

Application Number020732
Application Type New Drug Application
Sponsor ApplicantINDIVIOR INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/2002N3318000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf 10/8/2002
AP010/8/2002N3319000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf 10/8/2002
AP010/8/2002N10644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm 11/22/2004
AP010/8/2002N31351000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=352 1/5/2012
AP010/4/2006SLR15098002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf 10/13/2006
AP012/22/2011SLR31252006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007mg.pdf 12/23/2011
AP012/22/2011SLR31254006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf 12/23/2011
AP012/22/2011SLR31315006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf 1/3/2012
AP012/22/2011SLR31316007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf 1/3/2012
AP012/22/2011SLR31255007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf 12/23/2011
AP012/22/2011SLR31253007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007mg.pdf 12/23/2011
AP08/8/2013SCM       
AP012/11/2014SLR41233010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020732Orig1s010ltr.pdf 12/12/2014
AP012/11/2014SLR41311010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf 12/18/2014
AP09/22/2015S43981012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf 9/24/2015
AP07/7/2016S46498013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf 7/12/2016




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