← FDA DRUG APPROVALS

FDA NDA · NDA010596

CELONTIN

methsuximide

Sponsor: PARKE DAVIS

APPLICATION
NDA010596
TYPE
NDA
ORIGINAL APPROVAL
1957-02-08
LATEST ACTION
2011-06-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

CELONTIN · ReferenceDiscontinued
METHSUXIMIDE 150MG · CAPSULE · ORAL
CELONTIN · ReferencePrescription
METHSUXIMIDE 300MG · CAPSULE · ORAL

Approval history

2011-06-15REMS · Supplement 23 — Letter ↗AP
2010-10-11Labeling · Supplement 22 · standard — Label ↗AP
2009-04-23Labeling · Supplement 21 · 901 required — Letter ↗AP
2002-04-17Labeling · Supplement 17 · standard — Letter ↗AP
2001-04-09Labeling · Supplement 12 · standard — Letter ↗AP
2001-04-09Labeling · Supplement 9 — Letter ↗AP
2000-04-11Manufacturing (CMC) · Supplement 16 · priorityAP
1999-04-12Manufacturing (CMC) · Supplement 15 · priorityAP
1997-10-20Manufacturing (CMC) · Supplement 13 · priorityAP
1995-12-11Manufacturing (CMC) · Supplement 11 · priorityAP
1990-01-24Labeling · Supplement 10AP
1987-08-20Manufacturing (CMC) · Supplement 8 · priorityAP
1981-01-27Manufacturing (CMC) · Supplement 6 · priorityAP
1981-01-27Manufacturing (CMC) · Supplement 7 · priorityAP
1977-05-23Labeling · Supplement 4AP
1957-02-08Type 1 - New Molecular Entity · Original · priority — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

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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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