NDA 22578, held by Kenvue Brands. Cetirizine Hydrochloride.
As of Nov 14, 2026, NDA 22578 (Zyrtec Allergy), held by Kenvue Brands, was first approved by FDA on Sep 3, 2010, with 7 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zyrtec Allergy10MG · tablet, orally disintegrating;oral | Cetirizine Hydrochloride | OTCReference drug |
| Jul 2, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Nov 15, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Aug 23, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Aug 1, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 24, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2014 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 1, 2011 | Supplement 1Labeling | Approved | |
| Sep 3, 2010 | 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
