NDA 209090, held by Chattem Sanofi. Levocetirizine Dihydrochloride.
As of Nov 14, 2026, NDA 209090 (Xyzal Allergy 24hr), held by Chattem Sanofi, was first approved by FDA on Jan 31, 2017, with 6 approved supplements and 0 published complete response letters.
Use s 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 24hr2.5MG/5ML · solution;oral | Levocetirizine Dihydrochloride | OTCReference drug |
| Aug 31, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Mar 5, 2026 | Supplement 7Labeling · Standard review | Approved | |
| Jul 22, 2025 | Supplement 6Manufacturing | Approved | |
| Oct 28, 2022 | Supplement 4Manufacturing · Standard review | Approved | |
| Jul 13, 2022 | Supplement 3Manufacturing | Approved | |
| Nov 10, 2020 | Supplement 2Labeling · 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
