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FDA Drug Application 021018 by LILLY

Application Number021018
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/1999N919000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf 12/22/1999
AP012/22/1999N920000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21018lbl.pdf 12/22/1999
AP012/22/1999N2226000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21017_Humalog.cfm 12/22/1999
AP02/8/2002SLR       
AP03/21/2002SCS       
AP04/5/2002SCS       
AP010/25/2002SCS       
AP011/19/2003SCM6948011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21018scm011ltr.pdf 11/25/2003
AP011/19/2003SCM7017011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21018scm011_humalog_lbl.pdf 12/2/2003
AP09/7/2007SLR17855023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP09/6/2007SCP17866034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf 9/11/2007
AP09/6/2007SCP17825034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf 9/11/2007
AP05/1/2008SLR19778035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021018s035ltr.pdf 5/7/2008
AP08/22/2007SLR17698041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf 8/23/2007
AP08/22/2007SLR17715041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf 8/27/2007
AP03/16/2009SCS22029049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf 3/17/2009
AP03/16/2009SCS22073049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf 3/23/2009
AP03/21/2012SCM       
AP03/11/2013SLR35420067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf 3/11/2013
AP03/11/2013SLR35429067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s067ltr.pdf 3/12/2013
AP010/30/2011SLR30637069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021018s069lbl.pdf 11/16/2011
AP01/30/2013SLR35027077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s077ltr.pdf 1/31/2013
AP01/30/2013SLR35035077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s077lbl.pdf 2/1/2013
AP02/15/2013SCM       
AP03/28/2013SCM       
AP08/15/2013SCM       
AP03/18/2014SCM       
AP01/24/2014SCM       
AP04/3/2014SCM       
AP04/11/2014SCM       
AP06/4/2014SCM       
AP09/12/2014SCM       
AP02/25/2015SLR41928100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021018orig1s100ltr.pdf 2/27/2015
AP02/25/2015SLR41964100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021018s100lbl.pdf 3/2/2015
AP010/14/2016SCM       




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