NDA 20603, held by Kenvue Brands. Ibuprofen.
As of Nov 13, 2026, NDA 20603 (Children'S Motrin), held by Kenvue Brands, was first approved by FDA on Jun 10, 1996, with 11 approved supplements and 0 published complete response letters.
Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
| Apr 15, 1999 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 10, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Children'S Motrin40MG/ML · suspension/drops;oral | Ibuprofen | OTCReference drug |
| Mar 16, 2017 | Supplement 22Labeling · Standard review | Approved | |
| Aug 29, 2016 | Supplement 21Labeling · Standard review | Approved | |
| Dec 4, 2015 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 15, 2010 | Supplement 14Labeling | Approved | |
| Apr 29, 2009 | Supplement 13Labeling · Standard review | Approved | |
| Feb 27, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Jan 16, 2002 | Supplement 5Manufacturing · Standard review | Approved | |
| May 3, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1999 | Supplement 2Labeling · Standard review | Approved | |
| Apr 15, 1999 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 1998 | Supplement 1Labeling · Standard review | Approved | |
| Jun 10, 1996 | Original applicationNew dosage form · Standard 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
