APPLICATION
ANDA211699
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-15
LATEST ACTION
2022-03-15
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription
Products
BREYNAPrescription
BUDESONIDE 0.08MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION
BREYNAPrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION
Approval history
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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