APPLICATION
ANDA209959
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-08
LATEST ACTION
2025-11-21
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.09MG BASE/INH · AEROSOL, METERED · INHALATION
Approval history
2025-11-21Labeling · Supplement 21 · standardAP
2021-10-28Labeling · Supplement 10 · standardAP
2020-11-04Labeling · Supplement 7 · standardAP
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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