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FDA Drug Application 022386 by NOVO NORDISK INC

Application Number022386
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/2008N20076000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022386s000ltr.pdf 6/26/2008
AP06/23/2008N20090000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf 6/26/2008
AP06/23/2008N22236000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386s000_SumR.pdf 4/14/2009
AP06/23/2008N22237000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386_prandimet_toc.cfm 4/14/2009
AP05/28/2010SLR25685002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf 6/3/2010
AP05/28/2010SLR25702002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf 6/4/2010
AP03/1/2012SLR32029007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s007ltr.pdf 3/5/2012
AP03/1/2012SLR32042007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf 3/6/2012
AP04/24/2012SLR32538008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf 4/26/2012
AP04/24/2012SLR32544008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s008ltr.pdf 4/27/2012
AP010/17/2013SCM       
AP010/17/2013SCM       
AP06/11/2014SCM       
AP07/29/2014SCM       
AP06/4/2014SCM       
AP06/4/2014SCM       




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