APPLICATION
ANDA207659
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-18
LATEST ACTION
2025-01-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 500MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-01-27Labeling · Supplement 7 · standardAP
2024-03-21Labeling · Supplement 6 · standardAP
2023-05-19Labeling · Supplement 3 · standardAP
2018-10-18UNKNOWN · 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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