NDA 20601, held by Kenvue Brands. Ibuprofen.
As of Nov 13, 2026, NDA 20601 (Children'S Motrin, Junior Strength Motrin), held by Kenvue Brands, was first approved by FDA on Nov 15, 1996, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 1996 | Original applicationTYPE 8 · Standard review | Approved | None posted |
| Oct 2, 2018 | Supplement 21Labeling · Standard review | Approved | |
| May 15, 2017 | Supplement 20Labeling · Standard review | Approved | |
| Oct 18, 2010 | Supplement 18Labeling | Approved | |
| Apr 28, 2009 | Supplement 17Labeling · Standard review | Approved | |
| May 10, 2006 | Supplement 14Labeling · Standard review | Approved | |
| Feb 27, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Aug 5, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 2, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1999 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 29, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1999 | Supplement 2Labeling · Standard review | Approved | |
| Dec 18, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 15, 1996 | Original applicationTYPE 8 · 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
