APPLICATION
ANDA201966
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-27
LATEST ACTION
2021-03-31
ROUTE
INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
BUDESONIDEDiscontinued
BUDESONIDE 0.5MG/2ML · SUSPENSION · INHALATION
BUDESONIDEDiscontinued
BUDESONIDE 0.25MG/2ML · SUSPENSION · INHALATION
BUDESONIDEDiscontinued
BUDESONIDE 1MG/2ML · SUSPENSION · INHALATION
Approval history
2021-03-31Labeling · Supplement 9 · standardAP
2013-09-27Not Applicable · OriginalAP
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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