Treats symptoms of seasonal allergic rhinitis. NDA 211746, held by Glenmark Speclt. Mometasone Furoate; Olopatadine Hydrochloride.
As of Nov 13, 2026, NDA 211746 (Ryaltris), held by Glenmark Speclt, was first approved by FDA on Jan 13, 2022, with 4 approved supplements and 1 published complete response letter.
RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 2026 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jan 13, 2022 | Original applicationNew combination · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 20, 2019 | NDA 211746Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ryaltris0.025MG/SPRAY;0.665MG/SPRAY · spray, metered;nasal | Mometasone Furoate; Olopatadine Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 2026 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Aug 29, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Jun 7, 2023 | Supplement 3Manufacturing | Approved | |
| Sep 30, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Jan 13, 2022 | Original applicationNew combination · 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
