Back to FDA Applications sponsored by ELI LILLY AND CO

FDA Drug Application 022504 by ELI LILLY AND CO

Application Number022504
Application Type New Drug Application
Sponsor ApplicantELI LILLY AND CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/23/2010N27058000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022504s000ltr.pdf 11/29/2010
AP011/23/2010N27209000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022504s000lbl.pdf 11/23/2010
AP011/23/2010N28421000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249396.pdf 4/1/2011
AP011/23/2010N28443000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=7 4/4/2011
AP011/23/2010N30003000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504_axiron_toc.cfm 9/16/2011
AP011/23/2010N30004000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504Orig1s000SumR.pdf 9/16/2011
AP03/31/2011SLR28435002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf 4/1/2011
AP03/31/2011SLR28451002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s002ltr.pdf 4/4/2011
AP012/22/2011SLR31251005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf 12/23/2011
AP012/22/2011SLR31282005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s005ltr.pdf 12/28/2011
AP012/22/2011SLR39775005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022504Orig1s005.pdf 7/7/2014
AP01/15/2014SCM       
AP05/29/2013SCM       
AP02/27/2014SCM       
AP06/19/2014SLR39605011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022504Orig1s011ltr.pdf 6/23/2014
AP06/19/2014SLR39633011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022504s011lbl.pdf 6/23/2014
AP05/11/2015SLR42788012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022504Orig1s012ltr.pdf 5/13/2015
AP05/11/2015SLR42808012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf 5/13/2015
AP010/25/2016SLR47481014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022504Orig1s014ltr.pdf 10/27/2016
AP010/25/2016SLR47494014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022504s014lbl.pdf 10/28/2016




Back to FDA Applications sponsored by ELI LILLY AND CO