NDA 215712, held by Perrigo Pharma Intl. Mometasone Furoate.
As of Nov 13, 2026, NDA 215712 (Nasonex 24hr Allergy), held by Perrigo Pharma Intl, was first approved by FDA on Mar 17, 2022, with 8 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2022 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nasonex 24hr Allergy0.05MG/SPRAY · spray, metered;nasal | Mometasone Furoate | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2024 | Supplement 17Manufacturing | Approved | |
| May 24, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Mar 9, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Sep 20, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Sep 20, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Sep 19, 2022 | Supplement 11Labeling · Standard review | Tentative approval | |
| Sep 16, 2022 | Supplement 5Manufacturing | Approved | |
| Jul 15, 2022 | Supplement 6Manufacturing | Approved | |
| Jul 15, 2022 | Supplement 4Manufacturing | Approved | |
| Mar 17, 2022 | 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
