NDA 21587, held by Haleon US Holdings. Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride.
As of Nov 14, 2026, NDA 21587 (Children'S Advil Allergy Sinus), held by Haleon US Holdings, was first approved by FDA on Feb 24, 2004, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Children'S Advil Allergy Sinus1MG/5ML;100MG/5ML;15MG/5ML · suspension;oral | Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride | OTCReference drug |
| Mar 24, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Apr 4, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Feb 24, 2004 | 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
