NDA 21374, held by Haleon US Holdings. Ibuprofen; Pseudoephedrine Hydrochloride.
As of Nov 14, 2026, NDA 21374 (Advil Cold And Sinus), held by Haleon US Holdings, was first approved by FDA on May 30, 2002, with 8 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil Cold And SinusEQ 200MG FREE ACID AND POTASSIUM SALT;30MG · capsule;oral | Ibuprofen; Pseudoephedrine Hydrochloride | OTCReference drug |
| Nov 19, 2021 | Supplement 14Labeling · Standard review | Approved | |
| Mar 24, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Mar 14, 2011 | Supplement 9Labeling | Approved | |
| May 19, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Jun 23, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Apr 17, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Dec 7, 2005 | Supplement 5Labeling · Standard review | Approved | |
| Oct 17, 2003 | Supplement 1Labeling · Standard review | Approved | |
| May 30, 2002 | Original applicationNew dosage form · 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
