Junior Strength Motrin

NDA 20602, held by Kenvue Brands. Ibuprofen.

As of Nov 13, 2026, NDA 20602 (Junior Strength Motrin), held by Kenvue Brands, was first approved by FDA on Jun 10, 1996, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1996
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 10, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Junior Strength Motrin100MG · tablet;oral	Ibuprofen	OTC

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 15, 2017	Supplement 13Labeling · Standard review	Approved	Label Letter
Oct 13, 2010	Supplement 10Labeling	Approved	Letter
Apr 27, 2009	Supplement 9Labeling · Standard review	Approved	Letter
Feb 27, 2006	Supplement 8Labeling · Standard review	Approved	Letter
May 2, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 13, 1999	Supplement 3Labeling · Standard review	Approved	Letter Label Review
Jun 12, 1998	Supplement 1Labeling · Standard review	Approved	None posted
Jun 12, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Jun 10, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20602
Drugs@FDA: Overview at FDA
Company: Kenvue Brands

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