APPLICATION
ANDA206623
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-08
LATEST ACTION
2023-05-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2023-05-25Manufacturing (CMC) · Supplement 9 · standardAP
2023-05-25Labeling · Supplement 3 · standardAP
2023-05-25Labeling · Supplement 4 · 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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