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FDA Drug Application 022341 by NOVO NORDISK INC

Application Number022341
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
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
AP01/25/2010N24618000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf 1/26/2010
AP01/25/2010N24619000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf 1/26/2010
AP01/25/2010N24659000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM199170.pdf 1/29/2010
AP01/25/2010N24874000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=66 3/1/2010
AP01/25/2010N25228000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm 4/6/2010
AP012/22/2010SE827373001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf 12/26/2010
AP012/22/2010SE827374001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001MedG.pdf 12/26/2010
AP05/18/2011SLR28894004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf 5/23/2011
AP05/18/2011SLR28895004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004MedG.pdf 5/23/2011
AP05/18/2011SLR28909004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf 5/24/2011
AP04/6/2012SE832369007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf 4/9/2012
AP04/6/2012SE832375007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf 4/9/2012
AP04/6/2012SE832378007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013mg.pdf 4/9/2012
AP04/6/2012SE132379009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013mg.pdf 4/9/2012
AP04/6/2012SE132376009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf 4/9/2012
AP04/6/2012SE132370009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf 4/9/2012
AP012/3/2012SCM       
AP04/6/2012SLR32377013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf 4/9/2012
AP04/6/2012SLR32371013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf 4/9/2012
AP04/6/2012SLR32380013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013mg.pdf 4/9/2012
AP012/13/2012SLR34690017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf 12/18/2012
AP012/13/2012SLR34702017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf 12/19/2012
AP04/16/2013SLR35739018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf 4/17/2013
AP04/16/2013SLR35740018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018mg.pdf 4/17/2013
AP04/16/2013SLR35746018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf 4/18/2013
AP06/13/2013SLR36294020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf 6/14/2013
AP06/13/2013SLR36310020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf 6/18/2013
AP07/31/2014SLR40107021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf 8/1/2014
AP02/25/2015SLR41939022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s022ltr.pdf 2/27/2015
AP02/25/2015SLR42002022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf 3/3/2015
AP03/9/2015SLR42085023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s023ltr.pdf 3/11/2015
AP03/9/2015SLR42300023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf 3/26/2015
AP07/1/2015S43277024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf 7/8/2015
AP04/22/2016SE845746025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s025ltr.pdf 4/26/2016
AP04/22/2016SE845775025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf 4/27/2016
AP09/20/2016S47148026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s026ltr.pdf 9/22/2016




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