← FDA DRUG APPROVALS

FDA NDA · NDA012380

ZARONTIN

ethosuximide

Sponsor: PARKE DAVIS

APPLICATION
NDA012380
TYPE
NDA
ORIGINAL APPROVAL
1960-11-02
LATEST ACTION
2021-10-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZARONTIN · ReferencePrescription
ETHOSUXIMIDE 250MG · CAPSULE · ORAL

Approval history

2021-10-28Labeling · Supplement 37 · standard — Letter ↗AP
2016-05-17Labeling · Supplement 36 · standard — Letter ↗AP
2012-05-03Labeling · Supplement 34 · unknown — Medication Guide ↗AP
2011-06-15REMS · Supplement 33 — Letter ↗AP
2010-09-14Labeling · Supplement 32 · standard — Label ↗AP
2009-04-23Labeling · Supplement 31 · 901 required — Letter ↗AP
2006-09-01Labeling · Supplement 30 · standard — Letter ↗AP
2002-04-19Labeling · Supplement 29 · standard — Letter ↗AP
2001-04-09Labeling · Supplement 25 · standard — Letter ↗AP
2001-04-09Labeling · Supplement 23 — Letter ↗AP
2001-04-09Labeling · Supplement 22 — Letter ↗AP
2000-09-22Manufacturing (CMC) · Supplement 28 · priorityAP
2000-06-28Manufacturing (CMC) · Supplement 27 · priorityAP
1996-02-22Manufacturing (CMC) · Supplement 24 · priorityAP
1991-01-08Manufacturing (CMC) · Supplement 21 · priorityAP
1984-07-31Manufacturing (CMC) · Supplement 20 · priorityAP
1983-11-08Manufacturing (CMC) · Supplement 19 · priorityAP
1982-09-03Manufacturing (CMC) · Supplement 18 · priorityAP
1981-12-09Manufacturing (CMC) · Supplement 17 · priorityAP
1981-05-28Manufacturing (CMC) · Supplement 15 · priorityAP
1981-05-28Manufacturing (CMC) · Supplement 16 · priorityAP
1981-02-03Manufacturing (CMC) · Supplement 14 · priorityAP
1980-12-11Manufacturing (CMC) · Supplement 12 · priorityAP
1980-06-02Manufacturing (CMC) · Supplement 11 · priorityAP
1960-11-02Type 1 - New Molecular Entity · Original · priorityAP
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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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