← FDA DRUG APPROVALS

FDA NDA · NDA215712

RUGBY MOMETASONE FUROATE NASAL

mometasone furoate

Sponsor: PERRIGO PHARMA INTL

APPLICATION
NDA215712
TYPE
NDA
ORIGINAL APPROVAL
2022-03-17
LATEST ACTION
2024-06-07
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

NASONEX 24HR ALLERGY · ReferenceOver-the-counter
MOMETASONE FUROATE 0.05MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2024-06-07Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2023-05-24Labeling · Supplement 15 · standard — Letter ↗AP
2023-03-09Labeling · Supplement 12 · standard — Letter ↗AP
2022-09-20Labeling · Supplement 7 · standard — Letter ↗AP
2022-09-20Labeling · Supplement 8 · standard — Letter ↗AP
2022-09-19Labeling · Supplement 11 · standard — Letter ↗TA
2022-09-16Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2022-07-15Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2022-07-15Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2022-03-17Type 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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