APPLICATION
ANDA210588
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-17
LATEST ACTION
2026-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 125MG · TABLET · ORAL
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 250MG · TABLET · ORAL
Approval history
2026-04-02Labeling · Supplement 18 · standardAP
2025-03-13Labeling · Supplement 17 · standardAP
2023-08-09Labeling · Supplement 11 · standardAP
2019-10-17UNKNOWN · 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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