NDA 22565, held by Haleon US Holdings. Ibuprofen; Phenylephrine Hydrochloride.
As of Nov 14, 2026, NDA 22565 (Advil Congestion Relief), held by Haleon US Holdings, was first approved by FDA on May 27, 2010, with 5 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2010 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil Congestion Relief200MG;10MG · tablet;oral | Ibuprofen; Phenylephrine Hydrochloride | OTCReference drug |
| Nov 19, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Jul 30, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Jul 9, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Mar 24, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Mar 30, 2015 | Supplement 2Labeling · Standard review | Approved | |
| May 27, 2010 | Original applicationNew combination · 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
