APPLICATION
ANDA078404
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-31
LATEST ACTION
2021-03-31
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 0.5MG/2ML · SUSPENSION · INHALATION
BUDESONIDEPrescription
BUDESONIDE 0.25MG/2ML · SUSPENSION · INHALATION
Approval history
2021-03-31Labeling · Supplement 7 · standardAP
2012-07-31OriginalAP
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.