APPLICATION
ANDA077519
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-18
LATEST ACTION
2021-03-31
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 0.25MG/2ML · SUSPENSION · INHALATION
BUDESONIDEPrescription
BUDESONIDE 0.5MG/2ML · SUSPENSION · INHALATION
Approval history
2021-03-31Labeling · Supplement 14 · standardAP
2015-06-03Manufacturing (CMC) · Supplement 13 · unknownAP
2011-10-14Labeling · Supplement 6AP
2011-06-23Labeling · Supplement 1AP
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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