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FDA NDA · NDA216579

SYMBICORT AEROSPHERE

Sponsor: ASTRAZENECA

APPLICATION
NDA216579
TYPE
NDA
ORIGINAL APPROVAL
2023-04-28
LATEST ACTION
2026-04-27
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

SYMBICORT AEROSPHERE · ReferencePrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE 0.0048MG/INH · AEROSOL, METERED · INHALATION
SYMBICORT AEROSPHERE · ReferencePrescription
BUDESONIDE 0.08MG/INH, FORMOTEROL FUMARATE 0.0048MG/INH · AEROSOL, METERED · INHALATION

Approval history

2026-04-27Efficacy · Supplement 1 · standard — Label ↗AP
2023-04-28Efficacy · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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