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FDA ANDA · ANDA211600
ALBUTEROL SULFATE INHALATION
albuterol sulfate
Sponsor: AMNEAL IRELAND LTD
APPLICATION
ANDA211600
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-01
LATEST ACTION
2025-12-01
ROUTE
ORAL, INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.09MG BASE/INH · AEROSOL, METERED · INHALATION
Approval history
2025-12-01UNKNOWN · Original · 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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