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FDA Drug Application 206321 by NOVO NORDISK INC

Application Number206321
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type 10
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/2014N41474000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf 12/31/2014
AP012/23/2014N41475000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=342 12/31/2014
AP012/23/2014N41476000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf 12/31/2014
AP012/23/2014N44062000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000TOC.cfm 10/1/2015
AP03/27/2015SLR42321001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf 3/31/2015
AP03/27/2015SLR42369001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf 4/1/2015
AP02/1/2016S45072002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf 2/2/2016
AP02/1/2016S45271002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM487804.pdf 2/25/2016
AP09/22/2016SLR47191003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf 9/29/2016
AP09/22/2016SLR47327003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s003ltr.pdf 10/12/2016




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