Children'S Advil

NDA 19833, held by Haleon US Holdings. Ibuprofen.

As of Nov 13, 2026, NDA 19833 (Children'S Advil), held by Haleon US Holdings, was first approved by FDA on Sep 19, 1989, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1989
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 19, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Children'S Advil100MG/5ML · suspension;oral	Ibuprofen	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 8, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 26, 1998	Supplement 11Labeling · Standard review	Approved	Review
Oct 24, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 27, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 25, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 21, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 27, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 19, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19833
Drugs@FDA: Overview at FDA
Company: Haleon US Holdings

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