Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020563
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMALOG INSULIN LISPRO RECOMBINANT 100 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG KWIKPEN INSULIN LISPRO RECOMBINANT 100 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG PEN INSULIN LISPRO RECOMBINANT 100 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/14/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2018 SUPPL-191 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020563orig1s191,205747Orig1s018ltr.pdf
12/11/2018 SUPPL-190 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020563Orig1s190ltr.pdf
06/06/2017 SUPPL-176 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s176ltr.pdf
01/06/2017 SUPPL-172 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf
06/12/2015 SUPPL-163 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf
09/10/2015 SUPPL-161 Manufacturing (CMC)

Label is not available on this site.

06/11/2015 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

02/25/2015 SUPPL-157 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s157ltr.pdf
01/26/2015 SUPPL-156 Manufacturing (CMC)

Label is not available on this site.

11/11/2014 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

04/11/2014 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

04/03/2014 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

04/01/2014 SUPPL-147 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-145 Manufacturing (CMC)

Label is not available on this site.

03/04/2014 SUPPL-144 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-143 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-142 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-134 Manufacturing (CMC)

Label is not available on this site.

09/06/2013 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-132 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-131 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-127 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s127ltr.pdf
03/13/2015 SUPPL-124 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf
10/14/2012 SUPPL-123 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf
10/30/2011 SUPPL-117 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf
03/11/2013 SUPPL-115 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s115ltr.pdf
05/18/2011 SUPPL-105 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf
05/18/2011 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf
03/16/2009 SUPPL-91 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf
07/22/2007 SUPPL-82 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf
06/14/2007 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s076ltr.pdf
09/06/2007 SUPPL-75 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf
08/22/2007 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf
09/07/2007 SUPPL-64 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf
11/09/2005 SUPPL-60 Labeling

Label is not available on this site.

05/20/2005 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020563s054ltr.pdf
07/31/2014 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/21/2004 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr046ltr.pdf
11/19/2003 SUPPL-44 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm044ltr.pdf
09/29/2003 SUPPL-41 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf
06/24/2003 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020563Orig1s040.pdf
01/16/2004 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr036ltr.pdf
10/25/2002 SUPPL-35 Efficacy-New Indication

Label is not available on this site.

02/05/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2003 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr032ltr.pdf
05/11/2001 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/26/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2003 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf
07/07/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/14/2000 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/2004 SUPPL-24 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563se3-024ltr.pdf
05/23/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/25/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/11/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/12/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf
02/25/1999 SUPPL-15 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf
02/25/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF
04/04/2000 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF
04/04/2000 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF
04/04/2000 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF
09/04/1998 SUPPL-9 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf
08/06/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1997 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf
03/05/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/09/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/11/2018 SUPPL-190 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf
12/11/2018 SUPPL-190 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf
12/11/2018 SUPPL-190 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf
11/01/2018 SUPPL-191 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf
06/06/2017 SUPPL-176 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf
06/06/2017 SUPPL-176 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf
01/06/2017 SUPPL-172 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf
06/12/2015 SUPPL-163 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf
03/13/2015 SUPPL-124 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf
02/25/2015 SUPPL-157 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf
03/11/2013 SUPPL-115 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf
03/11/2013 SUPPL-115 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf
01/30/2013 SUPPL-127 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf
10/14/2012 SUPPL-123 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf
10/30/2011 SUPPL-117 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf
05/18/2011 SUPPL-105 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf
05/18/2011 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf
03/16/2009 SUPPL-91 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf
09/06/2007 SUPPL-75 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf
08/22/2007 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf
07/22/2007 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf
06/14/2007 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf
05/20/2005 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf
06/02/2004 SUPPL-24 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf
04/21/2004 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf
01/16/2004 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf
11/19/2003 SUPPL-44 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf
09/29/2003 SUPPL-41 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf
06/24/2003 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf
04/01/2003 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf
02/12/2003 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf
04/04/2000 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF
04/04/2000 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF
04/04/2000 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF
04/04/2000 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF
02/25/1999 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf

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