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FDA Drug Application 021462 by LILLY

Application Number021462
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/4/2004N7679000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf 2/5/2004
AP02/4/2004N7681000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462ppilbl.pdf 2/5/2004
AP02/4/2004N7682000Questions and Answers  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110262.htm 2/5/2004
AP02/4/2004N7683000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf 2/5/2004
AP02/4/2004N8097000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-462_Alimta.cfm 3/28/2004
AP02/4/2004N11412000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110261.htm 4/15/2005
AP08/19/2004SLR10022001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf 8/19/2004
AP08/19/2004SLR10033001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf 8/25/2004
AP07/28/2006SLR14584004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf 8/4/2006
AP07/28/2006SLR14605004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021462s004LTR.pdf 8/4/2006
AP02/2/2007SCM15791006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s006ltr.pdf 2/12/2007
AP02/2/2007SCM15869006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf 2/21/2007
AP09/7/2007SCS17829012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf 9/11/2007
AP09/7/2007SCS17851012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s012ltr.pdf 9/11/2007
AP09/26/2008S20896015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf 9/26/2008
AP09/26/2008S20907015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021462s015ltr.pdf 10/1/2008
AP09/26/2008S30060015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021462s015.pdf 9/22/2011
AP07/2/2009SLR22898018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf 7/8/2009
AP07/2/2009SLR22924018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf 7/9/2009
AP07/2/2009SE722866021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf 7/6/2009
AP07/2/2009SE722899021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf 7/8/2009
AP07/2/2009SLR22900022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf 7/8/2009
AP07/2/2009SLR22925022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf 7/9/2009
AP011/18/2011SE830734029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf 11/22/2011
AP011/18/2011SE830761029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf 11/23/2011
AP011/18/2011SLR30735030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf 11/22/2011
AP011/18/2011SLR30763030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf 11/25/2011
AP011/18/2011SE830733032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf 11/22/2011
AP011/18/2011SE830762032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf 11/25/2011
AP03/17/2011SE828305033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf 3/21/2011
AP03/17/2011SE828316033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s033ltr.pdf 3/23/2011
AP010/17/2012SE834114039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf 10/17/2012
AP010/17/2012SE834123039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s039ltr.pdf 10/18/2012
AP06/4/2012SLR32805040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf 6/5/2012
AP06/4/2012SLR32845040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462s040ltr.pdf 6/7/2012
AP03/13/2013SCM       
AP01/18/2013SCM34927042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf 1/22/2013
AP011/9/2012SLR34374043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s043ltr.pdf 11/14/2012
AP011/9/2012SLR34393043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf 11/15/2012
AP09/12/2013SLR37090045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf 9/13/2013
AP09/12/2013SLR37113045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf 9/17/2013
AP08/11/2014SCM       
AP01/8/2016SCM       




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