APPLICATION
ANDA040904
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-10
LATEST ACTION
2026-07-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 500MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-07-14Labeling · Supplement 26 · standardAP
2023-01-23Labeling · Supplement 12 · 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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