NDA 201803, held by Haleon US Holdings. Ibuprofen Sodium.
As of Nov 14, 2026, NDA 201803 (Advil), held by Haleon US Holdings, was first approved by FDA on Jun 12, 2012, with 9 approved supplements and 0 published complete response letters.
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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2012 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AdvilEQ 200MG BASE · tablet;oral | Ibuprofen Sodium | OTCReference drug |
| Feb 8, 2022 | Supplement 16Labeling · Standard review | Approved | |
| May 31, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Apr 12, 2018 | Supplement 11Labeling · Standard review | Approved | |
| Aug 22, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Jun 12, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Jun 3, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Nov 5, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 3, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 15, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2012 | Original applicationNew active ingredient · Standard review | Approved |
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
