APPLICATION
ANDA205457
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-03
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 9MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-09-16Labeling · Supplement 11 · standardAP
2023-10-10Labeling · Supplement 8 · standardAP
2023-10-10Labeling · Supplement 5 · standardAP
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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