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FDA ANDA · ANDA212212

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Sponsor: TEVA PHARMS USA INC

APPLICATION
ANDA212212
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-23
LATEST ACTION
2026-04-23
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEPrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEPrescription
BUDESONIDE 0.08MG/INH, FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · AEROSOL, METERED · INHALATION

Approval history

2026-04-23UNKNOWN · Original · standardAP
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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