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FDA NDA · NDA209022

XHANCE

fluticasone propionate

Sponsor: PARATEK PHARMS

APPLICATION
NDA209022
TYPE
NDA
ORIGINAL APPROVAL
2017-09-18
LATEST ACTION
2024-03-15
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

XHANCE · ReferencePrescription
FLUTICASONE PROPIONATE 0.093MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2024-03-15Efficacy · Supplement 19 · standard — Letter ↗AP
2023-01-20Labeling · Supplement 17 · standard — Letter ↗AP
2023-01-20Labeling · Supplement 13 · standard — Letter ↗AP
2021-04-29Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2021-04-29Labeling · Supplement 11 · standard — Letter ↗AP
2020-04-23Labeling · Supplement 9 · standard — Label ↗AP
2019-03-01Manufacturing (CMC) · Supplement 6AP
2018-03-19Labeling · Supplement 1 · standardAP
2017-09-18Type 5 - New Formulation or New Manufacturer · 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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