← FDA DRUG APPROVALS

FDA NDA · NDA022004

OMNARIS

ciclesonide

Sponsor: AZURITY

APPLICATION
NDA022004
TYPE
NDA
ORIGINAL APPROVAL
2006-10-20
LATEST ACTION
2019-05-08
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

OMNARIS · ReferencePrescription
CICLESONIDE 0.05MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2019-05-08Labeling · Supplement 18 · standard — Letter ↗AP
2016-03-17Labeling · Supplement 15 · unknown — Letter ↗AP
2013-06-12Manufacturing (CMC) · Supplement 16 · standardAP
2013-03-22Efficacy · Supplement 13 · standard — Label ↗AP
2010-05-07Labeling · Supplement 7 · unknown — Letter ↗AP
2010-05-07Labeling · Supplement 5 · standard — Label ↗AP
2007-11-21Labeling · Supplement 2 · standard — Letter ↗AP
2006-10-20Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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