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FDA Drug Application 021017 by LILLY

Application Number021017
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
AP012/22/1999N917000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf 12/22/1999
AP012/22/1999N918000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21017lbl.pdf 12/22/1999
AP012/22/1999N2225000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21017_Humalog.cfm 12/22/1999
AP02/8/2002SLR15227002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021017_S002_Humalog Mix_APPROVAL PACKAGE.pdf 10/25/2006
AP04/5/2002SCS       
AP010/25/2002SCS       
AP04/23/2004SLR8454006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf 4/29/2004
AP04/23/2004SLR8490006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf 5/4/2004
AP06/22/2003SLR6181010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017slr010ltr.pdf 7/28/2003
AP011/19/2003SCM6949013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017scm013ltr.pdf 11/25/2003
AP011/19/2003SCM7016013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21017scm013_humalog_lbl.pdf 12/2/2003
AP04/23/2004SLR8491015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf 5/4/2004
AP04/23/2004SLR8455015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf 4/29/2004
AP04/21/2004SCM8489018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017scm018_humalog_lbl.pdf 5/4/2004
AP04/21/2004SCM8453018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017scm018ltr.pdf 4/29/2004
AP011/9/2005SLR       
AP09/7/2007SLR17856029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP08/22/2007SLR17697030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf 8/23/2007
AP08/22/2007SLR17716030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf 8/27/2007
AP09/6/2007SCP17826040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf 9/11/2007
AP09/6/2007SCP17867040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf 9/11/2007
AP03/16/2009SCS22028053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf 3/17/2009
AP03/16/2009SCS22072053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf 3/23/2009
AP03/21/2012SCM       
AP03/11/2013SLR35421072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s072lbl.pdf 3/11/2013
AP03/11/2013SLR35424072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s072ltr.pdf 3/12/2013
AP010/30/2011SLR30636074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021017s074lbl.pdf 11/16/2011
AP01/30/2013SLR35028082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s082ltr.pdf 1/31/2013
AP01/30/2013SLR35034082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s082lbl.pdf 2/1/2013
AP06/12/2013SCM       
AP02/15/2013SCM       
AP05/10/2013SCM       
AP03/28/2013SCM       
AP08/15/2013SCM       
AP012/12/2013SCM       
AP03/4/2014SCM       
AP03/18/2014SCM       
AP01/24/2014SCM       
AP04/11/2014SCM       
AP06/4/2014SCM       
AP09/12/2014SCM       
AP02/25/2015SLR41927108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021017Orig1s108ltr.pdf 2/27/2015
AP02/25/2015SLR41965108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf 3/2/2015
AP04/24/2015SCM       




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