Advil Liqui-Gels, Advil Migraine Liqui-Gels

NDA 20402, held by Haleon US Holdings. Ibuprofen.

As of Nov 15, 2026, NDA 20402 (Advil Liqui-Gels, Advil Migraine Liqui-Gels), held by Haleon US Holdings, was first approved by FDA on Apr 20, 1995, with 26 approved supplements and 0 published complete response letters.

First approved: Apr 20, 1995
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Mar 16, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 20, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Advil Liqui-GelsEQ 200MG FREE ACID AND POTASSIUM SALT · capsule;oral	Ibuprofen	OTCReference drug
Advil Migraine Liqui-GelsEQ 200MG FREE ACID AND POTASSIUM SALT · capsule;oral	Ibuprofen	OTCReference drug

All 27 submissions, including labeling and manufacturing supplements


Jan 8, 2025	Supplement 58Labeling · Standard review	Approved	Label Letter
Feb 23, 2023	Supplement 55Labeling · Standard review	Approved	Letter Label
Jan 25, 2022	Supplement 53Labeling · Standard review	Approved	Label
Aug 31, 2018	Supplement 47Labeling · Standard review	Approved	Label Letter
Aug 2, 2018	Supplement 46Labeling · Standard review	Approved	Letter Label
Oct 18, 2017	Supplement 44Manufacturing · Standard review	Approved	Letter
Aug 8, 2017	Supplement 43Labeling · Standard review	Approved	Label Letter
Mar 8, 2017	Supplement 42Manufacturing	Approved	Label Letter
Dec 17, 2015	Supplement 40Manufacturing · Standard review	Approved	Label Letter
Sep 12, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 11, 2012	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 5, 2012	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 20, 2011	Supplement 27Labeling · Standard review	Approved	Label Letter
Jul 9, 2009	Supplement 26Manufacturing	Approved	Letter
May 19, 2009	Supplement 25Labeling · Standard review	Approved	Letter
Jun 11, 2008	Supplement 24Labeling · Standard review	Approved	Letter
Apr 28, 2006	Supplement 16Labeling · Standard review	Approved	Letter
Feb 8, 2006	Supplement 18Labeling · Standard review	Approved	Letter
Feb 26, 2004	Supplement 11Labeling · Standard review	Approved	Letter
Aug 2, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 28, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 16, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 9, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 23, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Oct 6, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 20, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20402
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