APPLICATION
ANDA077641
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-22
LATEST ACTION
2019-10-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ZONISAMIDEDiscontinued
ZONISAMIDE 25MG · CAPSULE · ORAL
ZONISAMIDEDiscontinued
ZONISAMIDE 100MG · CAPSULE · ORAL
ZONISAMIDEDiscontinued
ZONISAMIDE 50MG · CAPSULE · ORAL
Approval history
2019-10-25Labeling · Supplement 4 · standardAP
2007-12-12Labeling · Supplement 3AP
2007-06-14Labeling · Supplement 2AP
2006-12-21Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.