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FDA Drug Application 020427 by LUNDBECK LLC

Application Number020427
Application Type New Drug Application
Sponsor ApplicantLUNDBECK LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/21/2009N23230000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020427s000lbl.pdf 8/26/2009
AP08/21/2009N23231000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020427s000ltr.pdf 8/26/2009
AP08/21/2009N23270000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180720.pdf 9/2/2009
AP08/21/2009N24110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020427s000TOC.cfm 11/23/2009
AP08/21/2009N27652000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=48 2/2/2011
AP01/18/2011SLR27583002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002ltr.pdf 1/24/2011
AP01/18/2011SLR27588002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020427s002lbl.pdf 1/25/2011
AP012/11/2012SLR34607005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf 12/13/2012
AP012/11/2012SLR34667005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005lbl.pdf 12/14/2012
AP012/11/2012SLR34668005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005,022006s006mg.pdf 12/14/2012
AP012/14/2012SCM       
AP010/26/2013SLR37609010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013SLR37659010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP010/26/2013S37610011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013S37660011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP010/26/2013SLR37611012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013SLR37661012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP04/3/2014SLR38971013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf 4/4/2014
AP04/3/2014SLR38978013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006Orig1s014ltr.pdf 4/4/2014
AP06/21/2016S46400014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006Orig1s015ltr.pdf 6/23/2016
AP06/21/2016S46429014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf 6/27/2016
AP09/18/2015SLR43961015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006Orig1s016ltr.pdf 9/23/2015
AP09/18/2015SLR43962015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf 9/23/2015




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