NDA 209089, held by Chattem Sanofi. Levocetirizine Dihydrochloride.
As of Nov 14, 2026, NDA 209089 (Xyzal Allergy 24hr), held by Chattem Sanofi, was first approved by FDA on Jan 31, 2017, with 2 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2017 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xyzal Allergy 24hr5MG · tablet;oral | Levocetirizine Dihydrochloride | OTCReference drug |
| May 20, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Jul 11, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Jan 31, 2017 | Original applicationTYPE 8 · 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
