FDA NDA · NDA021658

ALVESCO

ciclesonide

Sponsor: AZURITY

APPLICATION

NDA021658

TYPE

NDA

ORIGINAL APPROVAL

2008-01-10

LATEST ACTION

2023-02-16

ROUTE

RESPIRATORY (INHALATION), INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Prescription

Products

ALVESCO · ReferencePrescription

CICLESONIDE 0.16MG/INH · AEROSOL, METERED · INHALATION

ALVESCO · ReferencePrescription

CICLESONIDE 0.08MG/INH · AEROSOL, METERED · INHALATION

2023-02-16Labeling · Supplement 11 · standard — Letter ↗AP

2014-04-22Manufacturing (CMC) · Supplement 8 · standardAP

2013-10-07Manufacturing (CMC) · Supplement 7 · standardAP

2012-12-17Efficacy · Supplement 6 · standard — Label ↗AP

2012-11-19Labeling · Supplement 5 · unknown — Label ↗AP

2008-12-22Labeling · Supplement 2 · standard — Letter ↗AP

2008-10-10Manufacturing (CMC) · Supplement 1AP

2008-01-10Type 3 - New Dosage Form · Original · standard — Review ↗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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