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FDA Drug Application 021897 by ALKERMES

Application Number021897
Application Type New Drug Application
Sponsor ApplicantALKERMES
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/13/2006N13939000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf 4/14/2006
AP04/13/2006N13970000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021897s000LTR.pdf 4/21/2006
AP04/13/2006N18878000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm 1/16/2008
AP04/13/2006N20586000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103334.htm 8/12/2008
AP04/13/2006N25148000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf 3/31/2010
AP04/13/2006N26642000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=67 10/13/2010
AP010/26/2007SLR18317003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf 11/7/2007
AP010/26/2007SLR18392003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021897s003ltr.pdf 11/8/2007
AP03/22/2010SLR25101005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf 3/25/2010
AP03/22/2010SLR25118005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010MedGuide.pdf 3/26/2010
AP03/22/2010SLR25121005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf 3/26/2010
AP03/22/2010SLR25119010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010MedGuide.pdf 3/26/2010
AP03/22/2010SLR25120010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf 3/26/2010
AP03/22/2010SLR25102010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf 3/25/2010
AP010/12/2010SE126640015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s015ltr.pdf 10/13/2010
AP010/12/2010SE126641015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf 10/13/2010
AP07/29/2013SLR39538020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf 6/12/2014
AP07/29/2013SLR36673020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf 7/31/2013
AP03/28/2013SCM       
AP07/29/2013SLR36674023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf 7/31/2013
AP07/29/2013SLR39539023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf 6/12/2014
AP02/9/2014SCM       
AP01/7/2014SCM       
AP04/17/2014SCM       
AP08/29/2014SCM       
AP01/26/2015SCM       
AP012/8/2015SCM44739029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf 12/10/2015
AP012/8/2015SCM44895029REMS  http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897Orig1s029Rems.pdf 12/29/2015
AP012/8/2015SCM44896029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021897Orig1s029Ltr.pdf 12/29/2015
AP01/19/2016SCM       
AP05/19/2016SCM       
AP05/17/2016S46065032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021897Orig1s032ltr.pdf 5/19/2016
AP010/4/2016SCM       




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