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FDA Drug Application 022410 by INDIVIOR INC

Application Number022410
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/30/2010N26357000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf 9/2/2010
AP08/30/2010N26472000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf 9/10/2010
AP08/30/2010N26485000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225677.pdf 9/15/2010
AP08/30/2010N26592000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=52 10/1/2010
AP08/30/2010N29749000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000TOC.cfm 8/12/2011
AP08/30/2010N29750000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000SumR.pdf 8/12/2011
AP04/28/2014SE839163004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf 4/29/2014
AP04/28/2014SE839173004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf 4/29/2014
AP08/10/2012SCM33456006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007mg.pdf 8/15/2012
AP08/10/2012SCM33458006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf 8/15/2012
AP08/10/2012SCM35235006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s006.pdf 2/25/2013
AP08/10/2012SCM33457007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007mg.pdf 8/15/2012
AP08/10/2012SCM33459007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf 8/15/2012
AP08/10/2012SCM35236007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s007.pdf 2/25/2013
AP08/8/2013SCM40151011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022410Orig1s011.pdf 8/5/2014
AP03/12/2014SCM40152014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s014.pdf 8/5/2014
AP011/22/2013SLR37908015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022410Orig1s015ltr.pdf 11/25/2013
AP011/22/2013SLR37940015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf 11/26/2013
AP06/5/2014SCM40153016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s016.pdf 8/5/2014
AP04/28/2014SLR39164017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf 4/29/2014
AP04/28/2014SLR39174017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf 4/29/2014
AP04/28/2014SE839165018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf 4/29/2014
AP04/28/2014SE839175018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf 4/29/2014
AP08/12/2014SCM       
AP09/22/2015SE843978020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf 9/24/2015
AP09/22/2015SE844130020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf 10/6/2015
AP06/23/2015SCM       
AP09/22/2015S43979022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf 9/24/2015
AP09/22/2015S44131022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf 10/6/2015
AP04/15/2016SCM       
AP07/7/2016S46500025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf 7/12/2016




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