APPLICATION
ANDA205710
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-16
LATEST ACTION
2021-11-16
ROUTE
ORAL, INHALATION
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
BUDESONIDEPrescription
BUDESONIDE 0.5MG/2ML · SUSPENSION · INHALATION
BUDESONIDEPrescription
BUDESONIDE 1MG/2ML · SUSPENSION · INHALATION
BUDESONIDEPrescription
BUDESONIDE 0.25MG/2ML · SUSPENSION · INHALATION
Approval history
2021-11-16Labeling · Supplement 17 · standardAP
2021-04-06Labeling · Supplement 9 · standardAP
2017-11-16UNKNOWN · Original · 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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