APPLICATION
ANDA078202
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-30
LATEST ACTION
2015-11-30
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
2015-11-30Labeling · Supplement 5 · standardAP
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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