← FDA DRUG APPROVALS

FDA NDA · NDA022051

FLONASE SENSIMIST ALLERGY RELIEF

fluticasone furoate

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA022051
TYPE
NDA
ORIGINAL APPROVAL
2007-04-27
LATEST ACTION
2025-12-19
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

FLONASE SENSIMIST ALLERGY RELIEF · ReferenceOver-the-counter
FLUTICASONE FUROATE 0.0275MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2025-12-19Labeling · Supplement 27 · standard — Letter ↗AP
2025-09-15Labeling · Supplement 25 · standard — Label ↗AP
2025-01-10Labeling · Supplement 24 · standard — Letter ↗AP
2024-10-24Labeling · Supplement 23 · standard — Label ↗AP
2023-11-15Labeling · Supplement 21 · standard — Letter ↗AP
2017-08-23Labeling · Supplement 17 · standard — Letter ↗AP
2017-04-05Labeling · Supplement 14 · standard — Label ↗AP
2016-08-02Efficacy · Supplement 13 · standard — Label ↗AP
2015-05-21Labeling · Supplement 11 · standardAP
2012-08-21Efficacy · Supplement 8 · standardAP
2011-10-13Labeling · Supplement 7 · standardAP
2011-09-01Labeling · Supplement 5 · standardAP
2009-07-28Labeling · Supplement 2 · standardAP
2007-04-27Type 2 - New Active Ingredient · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →