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FDA NDA · NDA205434

CHILDRENS FLONASE ALLERGY RELIEF

fluticasone propionate

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA205434
TYPE
NDA
ORIGINAL APPROVAL
2014-07-23
LATEST ACTION
2025-12-19
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

FLONASE ALLERGY RELIEF · ReferenceOver-the-counter
FLUTICASONE PROPIONATE 0.05MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2025-12-19Labeling · Supplement 18 · standard — Letter ↗AP
2025-01-10Labeling · Supplement 17 · standard — Label ↗AP
2024-10-24Labeling · Supplement 16 · standard — Label ↗AP
2023-11-15Labeling · Supplement 15 · standard — Letter ↗AP
2017-08-31Labeling · Supplement 5 · standard — Label ↗AP
2015-11-25Labeling · Supplement 3 · standard — Label ↗AP
2015-09-30Labeling · Supplement 1 · standard — Label ↗AP
2015-09-22Manufacturing (CMC) · Supplement 2 · standardAP
2014-07-23Type 8 - Partial Rx to OTC Switch · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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