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FDA NDA · NDA219622

TRIMBOW

beclomethasone dipropionate/formoterol fumarate/glycopyrrolate

Sponsor: CHIESI

APPLICATION
NDA219622
TYPE
NDA
ORIGINAL APPROVAL
2026-05-14
LATEST ACTION
2026-05-14
ROUTE
ORAL, INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

TRIMBOW · ReferencePrescription
BECLOMETHASONE DIPROPIONATE 0.086MG/INH, FORMOTEROL FUMARATE 0.0049MG/INH, GLYCOPYRROLATE 0.0106MG/INH · AEROSOL, METERED · INHALATION
TRIMBOW · ReferencePrescription
BECLOMETHASONE DIPROPIONATE 0.172MG/INH, FORMOTEROL FUMARATE 0.0049MG/INH, GLYCOPYRROLATE 0.0106MG/INH · AEROSOL, METERED · INHALATION

Approval history

2026-05-14Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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