APPLICATION
ANDA090379
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-02
LATEST ACTION
2014-04-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
BUDESONIDEDiscontinued
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
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.