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FDA ANDA · ANDA213811

BECLOMETHASONE DIPROPIONATE

Sponsor: AMNEAL IRELAND LTD

APPLICATION
ANDA213811
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-16
LATEST ACTION
2025-12-16
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

BECLOMETHASONE DIPROPIONATEPrescription
BECLOMETHASONE DIPROPIONATE 0.08MG/INH · AEROSOL, METERED · INHALATION
BECLOMETHASONE DIPROPIONATEPrescription
BECLOMETHASONE DIPROPIONATE 0.04MG/INH · AEROSOL, METERED · INHALATION

Approval history

2025-12-16UNKNOWN · Original · standardLetterAP
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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