NDA 205434, held by Haleon US Holdings. Fluticasone Propionate.
As of Nov 14, 2026, NDA 205434 (Flonase Allergy Relief), held by Haleon US Holdings, was first approved by FDA on Jul 23, 2014, 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 |
|---|---|---|---|
| Jul 23, 2014 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flonase Allergy Relief0.05MG/SPRAY · spray, metered;nasal | Fluticasone Propionate | OTCReference drug |
| Dec 19, 2025 | Supplement 18Labeling · Standard review | Approved | |
| Jan 10, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Oct 24, 2024 | Supplement 16Labeling · Standard review | Approved | |
| Nov 15, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Aug 31, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Nov 25, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Sep 30, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Sep 22, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 23, 2014 | 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
