APPLICATION
ANDA204691
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-29
LATEST ACTION
2024-12-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 500MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-12-12Labeling · Supplement 10 · standardAP
2023-06-06Labeling · Supplement 9 · standardAP
2016-03-29UNKNOWN · OriginalAP
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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