APPLICATION
ANDA205301
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-16
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 500MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-11-26Labeling · Supplement 5 · standardAP
2023-09-14Labeling · Supplement 3 · standardAP
2019-01-16UNKNOWN · 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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