Humalog, Humalog Pen, Humalog Kwikpen

BLA 20563, held by Lilly. Insulin Lispro Recombinant.

First approved: Jun 14, 1996
Review: Standard
Supplements approved: 84
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 85 submissions below

Date	Submission	Status	Documents
Oct 14, 2012	Supplement 123Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 18, 2011	Supplement 105Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 2, 2004	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 25, 2002	Supplement 35Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 4, 2000	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Apr 4, 2000	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2000	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 14, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

5 strengths and forms

Product	Active ingredient	Marketing
Humalog100 UNITS/ML · injectable;injection	Insulin Lispro Recombinant	Rx
Humalog Pen100 UNITS/ML · injectable;injection	Insulin Lispro Recombinant	Discontinued
Humalog Kwikpen100 UNITS/ML · injectable;injection	Insulin Lispro Recombinant	Rx
Humalog Kwikpen200UNITS/ML · injectable;injection	Insulin Lispro Recombinant	Rx
Humalog Tempo Pen100UNITS/ML · injectable;injection	Insulin Lispro Recombinant	Rx

All 85 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 7, 2025	Supplement 214Labeling · Standard review	Approved	Letter Label
Jul 21, 2023	Supplement 202Labeling · Standard review	Approved	Label Letter
Nov 15, 2019	Supplement 199Labeling	Approved	Letter Label
Nov 15, 2019	Supplement 198Labeling · Standard review	Approved	Label Letter
Nov 15, 2019	Supplement 196Labeling · Standard review	Approved	Letter Label
Aug 13, 2019	Supplement 195Labeling · Standard review	Approved	Label Letter
Dec 11, 2018	Supplement 190Labeling · Standard review	Approved	Letter Label
Nov 1, 2018	Supplement 191Labeling · Standard review	Approved	Letter Label
Jun 6, 2017	Supplement 176Labeling · Standard review	Approved	Letter Label
Jan 6, 2017	Supplement 172Labeling · Standard review	Approved	Letter Label
Sep 10, 2015	Supplement 161Manufacturing · Standard review	Approved	None posted
Jun 12, 2015	Supplement 163Labeling · Standard review	Approved	Letter Label
Jun 11, 2015	Supplement 159Manufacturing · Standard review	Approved	None posted
Mar 13, 2015	Supplement 124Labeling · Standard review	Approved	Letter Label
Feb 25, 2015	Supplement 157Labeling	Approved	Letter Label
Jan 26, 2015	Supplement 156Manufacturing · Standard review	Approved	None posted
Nov 11, 2014	Supplement 155Manufacturing · Standard review	Approved	None posted
Sep 12, 2014	Supplement 152Manufacturing · Standard review	Approved	None posted
Jul 31, 2014	Supplement 51Manufacturing · Standard review	Approved	None posted
Jun 4, 2014	Supplement 150Manufacturing · Standard review	Approved	None posted
Apr 11, 2014	Supplement 149Manufacturing · Standard review	Approved	None posted
Apr 3, 2014	Supplement 148Manufacturing · Standard review	Approved	None posted
Apr 1, 2014	Supplement 147Manufacturing · Standard review	Approved	None posted
Mar 18, 2014	Supplement 145Manufacturing · Standard review	Approved	None posted
Mar 4, 2014	Supplement 144Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 143Manufacturing · Standard review	Approved	None posted
Jan 24, 2014	Supplement 146Manufacturing · Standard review	Approved	None posted
Sep 6, 2013	Supplement 133Manufacturing · Standard review	Approved	None posted
Aug 21, 2013	Supplement 139Manufacturing · Standard review	Approved	None posted
Aug 15, 2013	Supplement 142Manufacturing · Standard review	Approved	None posted
Jul 18, 2013	Supplement 141Manufacturing · Standard review	Approved	None posted
Jun 12, 2013	Supplement 131Manufacturing · Standard review	Approved	None posted
May 10, 2013	Supplement 134Manufacturing · Standard review	Approved	None posted
Mar 28, 2013	Supplement 137Manufacturing · Standard review	Approved	None posted
Mar 14, 2013	Supplement 135Manufacturing · Standard review	Approved	None posted
Mar 11, 2013	Supplement 115Labeling · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 132Manufacturing · Standard review	Approved	None posted
Jan 30, 2013	Supplement 127Labeling · Standard review	Approved	Letter Label
Oct 14, 2012	Supplement 123Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 30, 2011	Supplement 117Labeling · Standard review	Approved	Label
May 18, 2011	Supplement 98Labeling	Approved	Letter Label
May 18, 2011	Supplement 105Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 16, 2009	Supplement 91Manufacturing · Standard review	Approved	Letter Label
Sep 7, 2007	Supplement 64Labeling · Standard review	Approved	Letter
Sep 6, 2007	Supplement 75Manufacturing · Standard review	Approved	Letter Label
Aug 22, 2007	Supplement 65Labeling · Standard review	Approved	Letter Label
Jul 22, 2007	Supplement 82Labeling · Standard review	Approved	Letter Label
Jun 14, 2007	Supplement 76Labeling · Standard review	Approved	Letter Label
Nov 9, 2005	Supplement 60Labeling · Standard review	Approved	None posted
May 20, 2005	Supplement 54Labeling · Standard review	Approved	Letter Label
Jun 2, 2004	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 21, 2004	Supplement 46Labeling · Standard review	Approved	Letter Label
Jan 16, 2004	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 19, 2003	Supplement 44Manufacturing · Standard review	Approved	Letter Label
Sep 29, 2003	Supplement 41Manufacturing · Standard review	Approved	Letter Label
Jun 24, 2003	Supplement 40Labeling · Standard review	Approved	Letter Label Other
Apr 1, 2003	Supplement 32Labeling · Standard review	Approved	Letter Label
Feb 12, 2003	Supplement 27Labeling · Standard review	Approved	Letter Label
Jan 2, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 35Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 5, 2002	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 17, 2001	Supplement 33Manufacturing · Standard review	Approved	None posted
May 11, 2001	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 26, 2001	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 11, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 7, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
May 23, 2000	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 4, 2000	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Apr 4, 2000	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2000	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 14, 2000	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 25, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 11, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
May 12, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 25, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 25, 1999	Supplement 15Manufacturing · Standard review	Approved	Label
Sep 4, 1998	Supplement 9Manufacturing · Standard review	Approved	Review
Aug 6, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 20, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 16, 1997	Supplement 3Labeling · Standard review	Approved	Review
Apr 29, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 5, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 9, 1997	Supplement 1Labeling · Standard review	Approved	None posted
Jun 14, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: BLA 20563
Drugs@FDA: Overview at FDA
Company: Lilly

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters