NDA 21441, held by Haleon US Holdings. Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride.
As of Nov 14, 2026, NDA 21441 (Advil Allergy Sinus), held by Haleon US Holdings, was first approved by FDA on Dec 19, 2002, with 7 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: runny nose itchy, watery eyes itching of the nose or throat sneezing nasal congestion sinus pressure headache minor aches and pains fever
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2002 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil Allergy Sinus2MG;200MG;30MG · tablet;oral | Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride | OTCReference drug |
| Nov 23, 2021 | Supplement 16Labeling · Standard review | Approved | |
| Mar 24, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Aug 31, 2010 | Supplement 11Labeling | Approved | |
| May 19, 2009 | Supplement 9Labeling · Standard review | Approved | |
| Jun 23, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Feb 27, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Jul 9, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Dec 19, 2002 | 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
