APPLICATION
ANDA206134
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-04
LATEST ACTION
2024-11-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2024-11-07Labeling · Supplement 9 · standardAP
2021-04-12Labeling · Supplement 1 · standardAP
2021-04-12Manufacturing (CMC) · Supplement 6 · standardAP
2021-04-12Labeling · Supplement 4 · standardAP
2017-05-04UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.