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FDA Drug Application 022321 by ALPHARMA PHARMS

Application Number022321
Application Type New Drug Application
Sponsor ApplicantALPHARMA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/13/2009N33131000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP08/13/2009N23201000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022321s000lbl.pdf 8/18/2009
AP08/13/2009N23204000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf 8/19/2009
AP08/13/2009N23273000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM179172.pdf 9/2/2009
AP08/13/2009N25609000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022321s000TOC.cfm 5/25/2010
AP08/13/2009N44374000FDA has determined that this product has abuse-deterrent properties  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 11/4/2015
AP07/9/2012SLR33116007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022321s007ltr.pdf 7/11/2012
AP07/9/2012SLR33154007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022321s007lbl.pdf 7/12/2012
AP01/17/2013SCM       
AP04/15/2013SLR35743010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s010ltr.pdf 4/18/2013
AP06/3/2013SLR36197012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s012lbl.pdf 6/3/2013
AP06/3/2013SLR36203012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022321Orig1s012ltr.pdf 6/4/2013
AP011/1/2013SCM37693013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022321s013lbl.pdf 11/5/2013
AP01/22/2014SCM       
AP010/17/2014SE840824016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s016lbl.pdf 10/17/2014
AP010/17/2014SE840825016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s016ltr.pdf 10/17/2014
AP010/17/2014SE840826016   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm 10/17/2014
AP04/16/2014SLR39060017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022321s017lbl.pdf 4/16/2014
AP04/16/2014SLR39075017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s017ltr.pdf 4/17/2014
AP08/19/2014S40276018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s018ltr.pdf 8/20/2014
AP06/26/2015S43251019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022321Orig1s019ltr.pdf 7/6/2015
AP011/10/2015SCM       
AP04/20/2016S45722021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s021ltr.pdf 4/22/2016
AP09/30/2016S47271023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022321Orig1s023ltr.pdf 10/4/2016




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