APPLICATION
ANDA215217
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-26
LATEST ACTION
2026-05-26
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE · SOLUTION · INHALATION
Approval history
2026-05-26UNKNOWN · 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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