APPLICATION
ANDA040430
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-28
LATEST ACTION
2022-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ETHOSUXIMIDEPrescription
ETHOSUXIMIDE 250MG · CAPSULE · ORAL
Approval history
2022-02-16Labeling · Supplement 19 · standardAP
2020-04-01Labeling · Supplement 13 · standardAP
2014-01-07Labeling · Supplement 8 · standardAP
2012-10-19REMS · Supplement 7AP
2011-12-27Labeling · Supplement 6AP
2009-12-10Labeling · Supplement 5AP
2008-03-03Labeling · Supplement 4AP
2002-10-28OriginalAP
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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