For diabetes mellitus. BLA 18781, held by Lilly. Insulin Susp Isophane Recombinant Human.
As of Nov 13, 2026, BLA 18781 (Humulin N), held by Lilly, was first approved by FDA on Oct 28, 1982, with 113 approved supplements and 0 published complete response letters.
HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. HUMULIN N is an intermediate-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 1982 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Humulin N100 UNITS/ML · injectable;injection | Insulin Susp Isophane Recombinant Human | OTC |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2022 | Supplement 193Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 187Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 188Labeling | Approved | |
| Aug 22, 2019 | Supplement 184Labeling · Standard review | Approved | |
| Nov 6, 2018 | Supplement 181Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 167Labeling · Standard review | Approved | |
| Apr 22, 2016 | Supplement 161Manufacturing · Standard review | Approved | None posted |
| Apr 5, 2016 | Supplement 163Manufacturing · Standard review | Approved | None posted |
| Feb 19, 2016 | Supplement 160Manufacturing · Standard review | Approved | None posted |
| Oct 20, 2015 | Supplement 159Manufacturing · Standard review | Approved | None posted |
| Oct 8, 2015 | Supplement 158Manufacturing · Standard review | Approved | None posted |
| Jul 15, 2015 | Supplement 157Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2015 | Supplement 156Labeling · Standard review | Approved | |
| Mar 3, 2015 | Supplement 155Manufacturing · Standard review | Approved | None posted |
| Feb 25, 2015 | Supplement 154Labeling | Approved | |
| Jan 12, 2015 | Supplement 153Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 120Manufacturing · Standard review | Approved | |
| Sep 12, 2014 | Supplement 150Manufacturing · Standard review | Approved | None posted |
| Jun 10, 2014 | Supplement 146Manufacturing · Standard review | Approved | None posted |
| Jun 4, 2014 | Supplement 147Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2014 | Supplement 143Manufacturing · Standard review | Approved | None posted |
| Apr 3, 2014 | Supplement 142Manufacturing · Standard review | Approved | None posted |
| Mar 18, 2014 | Supplement 140Manufacturing · Standard review | Approved | None posted |
| Mar 4, 2014 | Supplement 139Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2014 | Supplement 141Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2014 | Supplement 145Labeling · Standard review | Approved | |
| Dec 12, 2013 | Supplement 137Manufacturing · Standard review | Approved | None posted |
| Dec 9, 2013 | Supplement 144Labeling · Standard review | Approved | |
| Nov 7, 2013 | Supplement 122Labeling · Standard review | Approved | |
| Nov 7, 2013 | Supplement 118Labeling | Approved | |
| Aug 21, 2013 | Supplement 132Manufacturing · Standard review | Approved | None posted |
| Aug 15, 2013 | Supplement 136Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2013 | Supplement 126Manufacturing · Standard review | Approved | None posted |
| May 31, 2013 | Supplement 134Manufacturing · Standard review | Approved | None posted |
| May 30, 2013 | Supplement 133Manufacturing · Standard review | Approved | None posted |
| May 10, 2013 | Supplement 129Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2013 | Supplement 130Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2013 | Supplement 121Labeling | Approved | |
| Feb 21, 2013 | Supplement 131Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2013 | Supplement 128Manufacturing · Standard review | Approved | None posted |
| Dec 3, 2012 | Supplement 125Manufacturing · Standard review | Approved | None posted |
| Mar 21, 2012 | Supplement 113Manufacturing · Standard review | Approved | None posted |
| Jun 10, 2010 | Supplement 114Labeling | Approved | |
| Mar 16, 2009 | Supplement 108Manufacturing · Standard review | Approved | |
| Sep 7, 2007 | Supplement 88Labeling · Standard review | Approved | |
| Aug 22, 2007 | Supplement 89Labeling · Standard review | Approved | |
| Nov 9, 2005 | Supplement 85Labeling · Standard review | Approved | |
| Feb 25, 2005 | Supplement 80Manufacturing · Standard review | Approved | |
| Sep 3, 2004 | Supplement 79Labeling · Standard review | Approved | |
| Apr 21, 2004 | Supplement 76Labeling · Standard review | Approved | |
| Nov 20, 2003 | Supplement 70Labeling · Standard review | Approved | |
| Nov 20, 2003 | Supplement 60Labeling · Standard review | Approved | |
| Nov 19, 2003 | Supplement 74Manufacturing · Standard review | Approved | |
| Jun 22, 2003 | Supplement 72Labeling · Standard review | Approved | |
| Feb 12, 2003 | Supplement 57Labeling · Standard review | Approved | |
| Nov 5, 2002 | Supplement 54Labeling · Standard review | Approved | |
| Oct 31, 2002 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Aug 29, 2002 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Aug 29, 2002 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Aug 29, 2002 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2002 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2002 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Apr 2, 2002 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jul 7, 2000 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1999 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1999 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1998 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1998 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1997 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1997 | Supplement 47Labeling · Standard review | Approved | None posted |
| Jan 28, 1997 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1996 | Supplement 44Labeling · Standard review | Approved | None posted |
| May 31, 1996 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| May 22, 1996 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1996 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 26, 1996 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1995 | Supplement 38Labeling · Standard review | Approved | None posted |
| Oct 27, 1995 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1995 | Supplement 37Labeling · Standard review | Approved | None posted |
| Mar 9, 1995 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1995 | Supplement 35Labeling | Approved | None posted |
| Feb 10, 1995 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1994 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1992 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1991 | Supplement 27Labeling | Approved | |
| Mar 12, 1991 | Supplement 30Labeling | Approved | None posted |
| Sep 24, 1990 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1990 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1989 | Supplement 26Labeling | Approved | None posted |
| Jul 29, 1988 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1988 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1988 | Supplement 23Labeling | Approved | None posted |
| Mar 3, 1988 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1987 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1987 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1987 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1987 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1987 | Supplement 14Labeling | Approved | None posted |
| Jul 28, 1987 | Supplement 16Labeling | Approved | None posted |
| Jul 13, 1987 | Supplement 17Labeling | Approved | None posted |
| Jul 13, 1987 | Supplement 18Labeling | Approved | None posted |
| Jul 10, 1987 | Supplement 19Labeling | Approved | None posted |
| Feb 14, 1985 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 26, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1984 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 29, 1984 | Supplement 8Labeling | Approved | None posted |
| Oct 12, 1983 | Supplement 6Labeling | Approved | None posted |
| Aug 24, 1983 | Supplement 5Labeling | Approved | None posted |
| Jan 31, 1983 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1983 | Supplement 4Labeling | Approved | None posted |
| Dec 2, 1982 | Supplement 1Labeling | Approved | None posted |
| Dec 2, 1982 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1982 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
