Humalog Mix 75/25, Humalog Mix 75/25 Kwikpen, Humalog Mix 75/25 Pen

BLA 21017, held by Lilly. Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant.

First approved: Dec 22, 1999
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Dec 22, 1999	Original applicationTYPE 3/4 · Standard review	Approved	Letter Label Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Humalog Mix 75/2575 UNITS/ML;25 UNITS/ML · injectable;injection	Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant	Rx
Humalog Mix 75/25 Kwikpen75 UNITS/ML;25 UNITS/ML · injectable;injection	Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant	Rx
Humalog Mix 75/25 Pen75 UNITS/ML;25 UNITS/ML · injectable;injection	Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant	Discontinued

All 38 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 21, 2023	Supplement 146Labeling · Standard review	Approved	Letter Label
Nov 15, 2019	Supplement 143Labeling	Approved	Label Letter
Nov 15, 2019	Supplement 141Labeling · Standard review	Approved	Label Letter
Sep 26, 2018	Supplement 79Labeling · Standard review	Approved	Label Letter
Sep 26, 2018	Supplement 75Labeling · Standard review	Approved	Label Letter
Jan 6, 2017	Supplement 122Labeling · Standard review	Approved	Label Letter
Apr 24, 2015	Supplement 110Manufacturing · Standard review	Approved	None posted
Feb 25, 2015	Supplement 108Labeling	Approved	Label Letter
Sep 12, 2014	Supplement 103Manufacturing · Standard review	Approved	None posted
Jun 4, 2014	Supplement 102Manufacturing · Standard review	Approved	None posted
Apr 11, 2014	Supplement 100Manufacturing · Standard review	Approved	None posted
Mar 18, 2014	Supplement 98Manufacturing · Standard review	Approved	None posted
Mar 4, 2014	Supplement 97Manufacturing · Standard review	Approved	None posted
Jan 24, 2014	Supplement 99Manufacturing · Standard review	Approved	None posted
Dec 12, 2013	Supplement 95Manufacturing · Standard review	Approved	None posted
Aug 15, 2013	Supplement 94Manufacturing · Standard review	Approved	None posted
Jun 12, 2013	Supplement 86Manufacturing · Standard review	Approved	None posted
May 10, 2013	Supplement 88Manufacturing · Standard review	Approved	None posted
Mar 28, 2013	Supplement 91Manufacturing · Standard review	Approved	None posted
Mar 11, 2013	Supplement 72Labeling · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 87Manufacturing · Standard review	Approved	None posted
Jan 30, 2013	Supplement 82Labeling · Standard review	Approved	Letter Label
Mar 21, 2012	Supplement 61Manufacturing · Standard review	Approved	None posted
Oct 30, 2011	Supplement 74Labeling · Standard review	Approved	Label
Mar 16, 2009	Supplement 53Manufacturing · Standard review	Approved	Letter Label
Sep 7, 2007	Supplement 29Labeling · Standard review	Approved	Letter
Sep 6, 2007	Supplement 40Manufacturing · Standard review	Approved	Letter Label
Aug 22, 2007	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 9, 2005	Supplement 25Labeling · Standard review	Approved	None posted
Apr 23, 2004	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 23, 2004	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 21, 2004	Supplement 18Manufacturing · Standard review	Approved	Letter Label
Nov 19, 2003	Supplement 13Manufacturing · Standard review	Approved	Letter Label
Jun 30, 2003	Supplement 10Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 5, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 8, 2002	Supplement 2Labeling · Standard review	Approved	Review
Dec 22, 1999	Original applicationTYPE 3/4 · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 21017
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