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FDA Drug Application 020563 by LILLY

Application Number020563
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/14/1996N       
AP01/9/1997SLR       
AP03/5/1997SCM       
AP07/16/1997SLR4289003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf 7/16/1997
AP02/20/1998SCP       
AP04/29/1997SCM       
AP08/6/1998SCP       
AP09/4/1998SCP17181009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf 7/9/2007
AP04/4/2000SE21057010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF 4/4/2000
AP04/4/2000SE21058010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF 4/4/2000
AP04/4/2000SE81059011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF 4/4/2000
AP04/4/2000SE81060011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF 4/4/2000
AP04/4/2000SE11061012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF 4/4/2000
AP04/4/2000SE11062012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF 4/4/2000
AP04/4/2000SE81063013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF 4/4/2000
AP04/4/2000SE81064013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF 4/4/2000
AP02/25/1999SCS       
AP02/25/1999SCM4274015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf 3/11/2003
AP01/2/2003SLR9057016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf 6/7/2004
AP05/12/1999SCS       
AP01/11/2000SCM       
AP02/25/2000SCM       
AP05/23/2000SCM       
AP06/2/2004SE39097024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563se3-024ltr.pdf 6/7/2004
AP06/2/2004SE39124024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf 6/7/2004
AP03/14/2000SCS       
AP07/7/2000SCM       
AP03/12/2003SLR9061027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf 6/7/2004
AP03/12/2003SLR4122027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf 3/5/2003
AP09/11/2000SCS       
AP03/26/2001SCS       
AP05/11/2001SCM       
AP04/1/2003SLR4852032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf 4/3/2003
AP04/1/2003SLR5293032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr032ltr.pdf 4/16/2003
AP012/17/2001SCS       
AP02/5/2002SCS       
AP010/25/2002SE1       
AP01/16/2004SLR7588036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr036ltr.pdf 1/22/2004
AP01/16/2004SLR7612036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf 1/22/2004
AP06/24/2003SLR6055040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr040ltr.pdf 7/6/2003
AP06/24/2003SLR6078040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf 7/8/2003
AP09/29/2003SCM6736041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf 10/8/2003
AP09/29/2003SCM6745041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf 10/9/2003
AP011/19/2003SCM6950044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm044ltr.pdf 11/25/2003
AP011/19/2003SCM9056044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf 6/7/2004
AP04/21/2004SLR8449046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr046ltr.pdf 4/29/2004
AP04/21/2004SLR8486046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf 5/4/2004
AP07/31/2014SCM       
AP05/20/2005SLR11696054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020563s054ltr.pdf 5/23/2005
AP05/20/2005SLR11697054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf 5/23/2005
AP011/9/2005SLR       
AP09/7/2007SLR17857064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP08/22/2007SLR17696065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf 8/23/2007
AP08/22/2007SLR17717065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf 8/27/2007
AP09/6/2007SCP17827075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf 9/11/2007
AP09/6/2007SCP17868075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf 9/11/2007
AP06/14/2007SLR16829076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf 6/27/2007
AP06/14/2007SLR16926076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s076ltr.pdf 7/5/2007
AP07/20/2007SLR17332082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf 7/24/2007
AP07/20/2007SLR17350082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf 7/24/2007
AP03/16/2009SCS22027091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf 3/17/2009
AP03/16/2009SCS22071091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf 3/23/2009
AP05/18/2011SLR28896098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf 5/23/2011
AP05/18/2011SLR28919098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf 5/24/2011
AP05/18/2011SE528920105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf 5/24/2011
AP05/18/2011SE528897105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf 5/23/2011
AP03/11/2013SLR35418115   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf 3/11/2013
AP03/11/2013SLR35443115   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s115ltr.pdf 3/13/2013
AP010/30/2011SLR30635117   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf 11/16/2011
AP010/12/2012SE334097123   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf 10/15/2012
AP010/12/2012SE334108123   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf 10/16/2012
AP03/13/2015SLR42151124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf 3/16/2015
AP03/13/2015SLR42450124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf 4/7/2015
AP01/30/2013SLR35029127   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s127ltr.pdf 1/31/2013
AP01/30/2013SLR35033127   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf 2/1/2013
AP06/12/2013SCM       
AP02/15/2013SCM       
AP09/6/2013SCM       
AP05/10/2013SCM       
AP03/14/2013SCM       
AP03/28/2013SCM       
AP08/21/2013SCM       
AP07/18/2013SCM       
AP08/15/2013SCM       
AP01/31/2014SCM       
AP03/4/2014SCM       
AP03/18/2014SCM       
AP01/24/2014SCM       
AP04/1/2014SCM       
AP04/3/2014SCM       
AP04/11/2014SCM       
AP06/4/2014SCM       
AP09/12/2014SCM       
AP011/11/2014SCM       
AP01/26/2015SCM       
AP02/25/2015SLR41923157   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s157ltr.pdf 2/27/2015
AP02/25/2015SLR41966157   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf 3/2/2015
AP06/11/2015SCM       
AP09/10/2015SCM       
AP06/12/2015SLR43060163   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf 6/15/2015
AP06/12/2015SLR43063163   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf 6/15/2015
AP09/22/2016SCM       
AP010/17/2016SCM       




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