FDA NDA · NDA202129

ZETONNA

Sponsor: AZURITY

APPLICATION

NDA202129

TYPE

NDA

ORIGINAL APPROVAL

2012-01-20

LATEST ACTION

2023-02-16

ROUTE

NASAL

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Discontinued

Products

ZETONNA · ReferenceDiscontinued

CICLESONIDE 0.037MG/INH · AEROSOL, METERED · NASAL

2023-02-16Labeling · Supplement 9 · standard — Letter ↗AP

2014-10-23Efficacy · Supplement 6 · standard — Label ↗AP

2014-10-23Efficacy · Supplement 4 · standard — Label ↗AP

2014-10-23Efficacy · Supplement 5 · standard — Label ↗AP

2014-04-22Manufacturing (CMC) · Supplement 3 · standardAP

2014-01-31Manufacturing (CMC) · Supplement 2 · standardAP

2012-12-20Manufacturing (CMC) · Supplement 1 · standardAP

2012-01-20Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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