NDA 20944, held by Haleon US Holdings. Ibuprofen.
As of Nov 13, 2026, NDA 20944 (Children'S Advil, Junior Strength Advil), held by Haleon US Holdings, was first approved by FDA on Dec 18, 1998, with 9 approved supplements and 0 published complete response letters.
USES temporarily:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 1998 | Original applicationNew dosage form · Standard review | Approved |
| May 1, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Dec 26, 2017 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 27, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Feb 13, 2014 | Supplement 10Manufacturing | Approved | None posted |
| May 19, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Jun 11, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Apr 4, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Dec 20, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Dec 20, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Dec 18, 1998 | Original applicationNew dosage form · Standard review | Approved |
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
