Back to FDA Applications sponsored by LUNDBECK LLC

FDA Drug Application 022006 by LUNDBECK LLC

Application Number022006
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/21/2009N23232000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022006s000ltr.pdf 8/26/2009
AP08/21/2009N23271000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180720.pdf 9/2/2009
AP08/21/2009N23599000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000TOC.cfm 10/16/2009
AP08/21/2009N23600000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000_SumR.pdf 10/16/2009
AP08/21/2009N27653000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=48 2/2/2011
AP01/18/2011SLR27584002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002ltr.pdf 1/24/2011
AP01/18/2011SLR27589002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022006s002lbl.pdf 1/25/2011
AP012/11/2012SLR34669006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005,022006s006mg.pdf 12/14/2012
AP012/11/2012SLR34670006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf 12/14/2012
AP010/26/2013SLR37608011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013SLR37656011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP010/26/2013SE837607012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013SE837657012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP010/26/2013SE137606013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf 10/29/2013
AP010/26/2013SE137658013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf 10/31/2013
AP04/3/2014SLR38970014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf 4/4/2014
AP04/3/2014SLR38979014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006Orig1s014ltr.pdf 4/4/2014
AP06/21/2016S46401015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006Orig1s015ltr.pdf 6/23/2016
AP06/21/2016S46428015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf 6/27/2016
AP09/18/2015SLR43933016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006Orig1s016ltr.pdf 9/22/2015
AP09/18/2015SLR43960016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf 9/23/2015
AP011/3/2015SLR44380017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022006Orig1s017lbl.pdf 11/4/2015
AP011/3/2015SLR44384017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022006Orig1s017ltr.pdf 11/4/2015




Back to FDA Applications sponsored by LUNDBECK LLC