APPLICATION
ANDA207367
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-07
LATEST ACTION
2026-01-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2026-01-26Labeling · Supplement 13 · standardAP
2023-10-23Labeling · Supplement 12 · standardAP
2022-11-15Labeling · Supplement 4 · standardAP
2017-04-07UNKNOWN · Original · 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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