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FDA ANDA · ANDA215328

BUDESONIDE

Sponsor: PADAGIS ISRAEL

APPLICATION
ANDA215328
TYPE
ANDA
ORIGINAL APPROVAL
2023-04-12
LATEST ACTION
2023-04-12
ROUTE
RECTAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Prescription

Products

BUDESONIDEPrescription
BUDESONIDE 2MG/ACTUATION · AEROSOL, FOAM · RECTAL

Approval history

2023-04-12UNKNOWN · Original · standardLetterAP
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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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