Treats acute urticaria. NDA 211415, held by Esteve. Cetirizine Hydrochloride.
As of Nov 13, 2026, NDA 211415 (Quzyttir), held by Esteve, was first approved by FDA on Oct 4, 2019, with 2 approved supplements and 0 published complete response letters.
QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Quzyttir10MG/ML (10MG/ML) · solution;intravenous | Cetirizine Hydrochloride | RxReference drug |
| Jul 28, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Nov 27, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Oct 4, 2019 | 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
