APPLICATION
ANDA078949
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-12
LATEST ACTION
2019-10-29
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription, Over-the-counter
Products
BUDESONIDEPrescription
BUDESONIDE 0.032MG/INH · SPRAY, METERED · NASAL
BUDESONIDEOver-the-counter
BUDESONIDE 0.032MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-10-29Labeling · Supplement 10 · standardAP
2015-11-20Labeling · Supplement 3 · standardAP
2014-05-12OriginalAP
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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