APPLICATION
ANDA204548
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-08
LATEST ACTION
2021-03-31
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 1MG/2ML · SUSPENSION · INHALATION
Approval history
2021-03-31Labeling · Supplement 3 · standardAP
2016-04-29Manufacturing (CMC) · Supplement 1 · unknownAP
2016-03-08UNKNOWN · 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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