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FDA Drug Application 021318 by LILLY

Application Number021318
Application Type New Drug Application
Sponsor ApplicantLILLY
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
AP011/26/2002N4637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21318.pdf 11/26/2001
AP011/26/2002N4638000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf 11/26/2001
AP011/26/2002N7272000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088604.pdf 12/17/2003
AP011/26/2002N8029000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm 3/24/2004
AP011/26/2002N32610000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=19 5/3/2012
AP06/2/2004SLR9087002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318slr002ltr.pdf 6/7/2004
AP06/2/2004SLR9129002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf 6/7/2004
AP09/3/2004SLR10135004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318s004ltr.pdf 9/7/2004
AP09/3/2004SLR10136004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf 9/7/2004
AP05/19/2007SLR16605009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021318s009ltr.pdf 5/29/2007
AP05/19/2007SLR16646009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf 5/29/2007
AP07/22/2009SE123016012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf 7/23/2009
AP07/22/2009SE123017012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf 7/23/2009
AP02/28/2008SLR19348015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s015ltr.pdf 3/4/2008
AP02/28/2008SLR19373015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf 3/5/2008
AP06/25/2008SCS20102016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s016ltr.pdf 6/30/2008
AP06/25/2008SCS30822016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021318Orig1s016.pdf 10/10/2011
AP08/10/2011SLR29765026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021318s026ltr.pdf 8/12/2011
AP03/13/2012SLR32113027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021318s027ltr.pdf 3/15/2012
AP02/15/2013SCM       
AP03/13/2013SCM       
AP08/2/2013SCM       
AP08/30/2013S36939036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf 9/4/2013
AP08/30/2013S37019036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf 9/9/2013
AP03/5/2014SCM       
AP01/24/2014SCM       
AP04/11/2014SCM       
AP08/13/2014SCM       
AP09/12/2014SCM       
AP011/23/2015SCM       
AP09/15/2016SCM       




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