APPLICATION
ANDA040253
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-22
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
ETHOSUXIMIDEPrescription
ETHOSUXIMIDE 250MG/5ML · SYRUP · ORAL
Approval history
2025-08-01Labeling · Supplement 10 · standardAP
2025-08-01Labeling · Supplement 5 · standardAP
2017-05-05Labeling · Supplement 4 · standardAP
2014-01-15Labeling · Supplement 3AP
2010-01-04Labeling · Supplement 2AP
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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