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FDA NDA · NDA214070

AIRSUPRA

albuterol sulfate and budesonide

Sponsor: ASTRAZENECA

APPLICATION
NDA214070
TYPE
NDA
ORIGINAL APPROVAL
2023-01-10
LATEST ACTION
2025-09-15
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

AIRSUPRA · ReferencePrescription
ALBUTEROL SULFATE EQ 0.09MG BASE/INH, BUDESONIDE 0.08MG/INH · AEROSOL, METERED · INHALATION

Approval history

2025-09-15Efficacy · Supplement 1 · standard — Label ↗AP
2023-01-10Type 4 - New Combination · Original · standard — Letter ↗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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