NDA 18989, held by Haleon US Holdings. Ibuprofen.
As of Nov 13, 2026, NDA 18989 (Advil), held by Haleon US Holdings, was first approved by FDA on May 18, 1984, with 59 approved supplements and 0 published complete response letters.
Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 1984 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil200MG · tablet;oral | Ibuprofen | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2024 | Supplement 104Labeling · Standard review | Approved | |
| Dec 14, 2021 | Supplement 99Labeling · Standard review | Approved | |
| Apr 10, 2020 | Supplement 95Manufacturing | Approved | None posted |
| Nov 14, 2018 | Supplement 91Labeling · Standard review | Approved | |
| Oct 2, 2018 | Supplement 90Labeling · Standard review | Approved | |
| Aug 23, 2017 | Supplement 88Labeling · Standard review | Approved | |
| Feb 3, 2017 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Apr 29, 2016 | Supplement 85Manufacturing · Priority review | Approved | None posted |
| Dec 16, 2015 | Supplement 84Manufacturing · Priority review | Approved | |
| May 18, 2015 | Supplement 83Manufacturing · Priority review | Approved | None posted |
| Apr 26, 2011 | Supplement 79Labeling | Approved | |
| Sep 1, 2010 | Supplement 80Labeling | Approved | |
| May 19, 2009 | Supplement 73Labeling · Standard review | Approved | |
| Jun 11, 2008 | Supplement 70Labeling · Standard review | Approved | |
| May 1, 2007 | Supplement 67Labeling · Standard review | Approved | |
| Apr 17, 2006 | Supplement 60Labeling · Standard review | Approved | |
| Apr 4, 2006 | Supplement 61Labeling · Standard review | Approved | |
| Jul 16, 2004 | Supplement 58Labeling · Standard review | Approved | |
| Sep 26, 2003 | Supplement 56Manufacturing · Priority review | Approved | |
| Apr 24, 2002 | Supplement 55Manufacturing · Priority review | Approved | |
| Sep 7, 2001 | Supplement 53Manufacturing · Priority review | Approved | |
| Aug 2, 2001 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Nov 15, 2000 | Supplement 52Labeling · Standard review | Approved | None posted |
| Nov 19, 1999 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Oct 4, 1999 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Oct 14, 1998 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Apr 3, 1997 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Dec 19, 1996 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Dec 3, 1996 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Aug 1, 1995 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1995 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1994 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Sep 7, 1994 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1994 | Supplement 37Labeling | Approved | None posted |
| Mar 11, 1994 | Supplement 36Labeling | Approved | None posted |
| Oct 18, 1993 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Oct 18, 1993 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1993 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1991 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1991 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1990 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1989 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1989 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| May 25, 1988 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| May 25, 1988 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| May 25, 1988 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| May 25, 1988 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| May 25, 1988 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| May 2, 1988 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Feb 1, 1988 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jan 17, 1987 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jan 6, 1987 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jul 5, 1986 | Supplement 15Labeling | Approved | None posted |
| May 30, 1986 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Dec 24, 1985 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Oct 19, 1985 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1985 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Dec 18, 1984 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 5, 1984 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| May 18, 1984 | Original applicationNew dosage form · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
