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FDA Drug Application 018936 by ELI LILLY AND CO

Application Number018936
Application Type New Drug Application
Sponsor ApplicantELI LILLY AND CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1987N12432000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
AP012/29/1987N24059000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf 11/20/2009
AP05/6/1988SCS       
AP09/28/1988SCS       
AP011/21/1996SE1       
AP09/28/1988SCP       
AP06/22/1988SLR       
AP010/26/1988SCM       
AP011/17/1988SLR       
AP011/17/1988SLR       
AP02/17/1989SCS       
AP02/16/1989SLR       
AP02/8/1989SCS       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP06/7/1990SLR       
AP04/9/1991SLR       
AP04/9/1991SLR       
AP01/21/1992SLR       
AP012/23/1992SCF       
AP01/21/1992SLR       
AP01/21/1992SLR       
AP08/20/1992SLR       
AP08/18/1993SLR       
AP03/25/1993SLR       
AP01/9/1995SCM18637033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018936_S033_PROZAC.pdf 12/6/2007
AP07/6/1994SLR       
AP03/25/1997SLR6682036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18936S036_ProzacPulvules.pdf 9/25/2003
AP03/1/1995SLR       
AP09/12/1995SLR       
AP03/1/1995SCS       
AP09/12/1995SLR       
AP012/30/1996SCM       
AP09/17/1997SCS       
AP04/3/1998SCP       
AP07/6/1998SCM       
AP03/13/1998SLR       
AP010/7/1999SLR9960052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm 8/9/2004
AP05/29/1998SCM       
AP06/15/1999SCF9962054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936s054_Prozac.cfm 8/9/2004
AP010/20/1998SCS       
AP02/11/1999SCM       
AP07/6/2000SE11161058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18936S58LTR.PDF 7/6/2000
AP07/6/2000SE11162058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF 7/6/2000
AP06/16/1999SLR       
AP011/28/2000SLR15829060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm 2/20/2007
AP011/28/2000SLR15830062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm 2/20/2007
AP011/28/2000SLR15831063   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm 2/20/2007
AP01/3/2003SE52726064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf 1/7/2003
AP01/3/2003SE54191064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18936se5-064ltr.pdf 1/7/2003
AP01/3/2003SE56678064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18936s064_Prozac.cfm 9/25/2003
AP07/29/2002SE8       
AP06/12/2002SE23229067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18936s067ltr.pdf 6/12/2002
AP06/12/2002SE23230067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf 6/12/2002
AP08/19/2004SLR10040069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf 8/25/2004
AP09/3/2004SLR10130070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18936s070ltr.pdf 9/3/2004
AP012/1/2005SLR13210071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf 12/5/2005
AP02/18/2005SLR11158072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf 2/23/2005
AP012/1/2005SLR13211073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf 12/5/2005
AP04/11/2006SLR13915074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf 4/13/2006
AP03/19/2009SLR22062075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf 3/20/2009
AP03/19/2009SLR22084075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf 3/24/2009
AP09/20/2006SLR14939076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf 9/21/2006
AP03/19/2009SE822063077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf 3/20/2009
AP03/19/2009SE822083077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf 3/24/2009
AP03/15/2007SLR16066078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf 3/23/2007
AP03/15/2007SLR44388078   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/018936Orig1s078.pdf 11/5/2015
AP08/2/2007SLR17478081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf 8/3/2007
AP08/2/2007SLR17586081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP08/2/2007SLR17479082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf 8/3/2007
AP08/2/2007SLR17587082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP03/9/2008SLR19425083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf 3/12/2008
AP03/9/2008SLR19447083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf 3/13/2008
AP03/21/2008SLR19506084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf 3/24/2008
AP03/21/2008SLR19524084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf 3/24/2008
AP06/26/2008SLR20103086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf 6/30/2008
AP06/26/2008SLR20138086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s086ltr.pdf 7/1/2008
AP01/30/2009SLR21707088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf 2/3/2009
AP01/30/2009SLR21753088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf 2/4/2009
AP06/22/2009SLR22814089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s089ltr.pdf 6/24/2009
AP06/22/2009SLR22819089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf 6/24/2009
AP04/4/2011SLR28463091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf 4/4/2011
AP04/4/2011SLR28527091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP04/4/2011SLR29147091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP04/4/2011SLR28464093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf 4/4/2011
AP04/4/2011SLR28528093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP04/4/2011SLR29148093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP04/4/2011SLR37478093   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936Orig1s093.pdf 10/21/2013
AP04/4/2011SLR28465095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf 4/4/2011
AP04/4/2011SLR28529095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP04/4/2011SLR29149095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP06/15/2011SLR29157096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf 6/16/2011
AP06/15/2011SLR29173096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf 6/16/2011
AP01/3/2013SLR34835097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020mg.pdf 1/7/2013
AP01/3/2013SLR34837097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf 1/7/2013
AP01/3/2013SLR34843097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf 1/7/2013
AP01/3/2013SLR44507097   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018936Orig1s097.pdf 11/18/2015
AP01/3/2013SLR34836098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020mg.pdf 1/7/2013
AP01/3/2013SLR34838098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf 1/7/2013
AP01/3/2013SLR34844098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf 1/7/2013
AP07/26/2013SLR36639100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf 7/30/2013
AP07/26/2013SLR36667100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP07/26/2013S36640101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf 7/30/2013
AP07/26/2013S36668101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP010/10/2014SE840774102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf 10/15/2014
AP010/10/2014SE840785102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf 10/15/2014
AP07/18/2014SLR39949105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf 7/23/2014
AP07/18/2014SLR39990105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf 7/24/2014
AP011/24/2015SLR44577106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018936Orig1s106ltr.pdf 11/25/2015
AP08/1/2016SCM       




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