← FDA DRUG APPROVALS

FDA NDA · NDA020789

ZONEGRAN

zonisamide

Sponsor: ADVANZ PHARMA

APPLICATION
NDA020789
TYPE
NDA
ORIGINAL APPROVAL
2000-03-27
LATEST ACTION
2020-04-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

ZONEGRAN · ReferencePrescription
ZONISAMIDE 100MG · CAPSULE · ORAL
ZONEGRAN · ReferenceDiscontinued
ZONISAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZONEGRAN · ReferencePrescription
ZONISAMIDE 25MG · CAPSULE · ORAL

Approval history

2020-04-13Labeling · Supplement 36 · 901 required — Label ↗AP
2016-04-06Labeling · Supplement 34 · standard — Label ↗AP
2015-11-12Manufacturing (CMC) · Supplement 33 · standardAP
2015-06-19Labeling · Supplement 21 · standard — Letter ↗AP
2013-10-11Manufacturing (CMC) · Supplement 32 · standardAP
2012-01-26Labeling · Supplement 12 · standard — Label ↗AP
2011-09-23Labeling · Supplement 30 · unknown — Letter ↗AP
2011-05-27REMS · Supplement 29 — Letter ↗AP
2010-04-19Labeling · Supplement 26 · standard — Label ↗AP
2010-04-19Labeling · Supplement 24 · standard — Label ↗AP
2009-04-23REMS · Supplement 22 — Label ↗AP
2009-04-23Labeling · Supplement 25 · standard — Letter ↗AP
2006-11-20Labeling · Supplement 19 · standard — Letter ↗AP
2003-08-22Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-10-07Labeling · Supplement 5 · standard — Label ↗AP
2002-06-13Manufacturing (CMC) · Supplement 8 · standardAP
2002-05-15Manufacturing (CMC) · Supplement 7 · standardAP
2002-04-01Manufacturing (CMC) · Supplement 6 · standardAP
2002-02-06Manufacturing (CMC) · Supplement 4 · standardAP
2001-11-28Manufacturing (CMC) · Supplement 3 · standardAP
2000-12-04Manufacturing (CMC) · Supplement 2 · standardAP
2000-03-27Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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