APPLICATION
ANDA077645
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-22
LATEST ACTION
2023-03-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZONISAMIDEPrescription
ZONISAMIDE 50MG · CAPSULE · ORAL
ZONISAMIDEPrescription
ZONISAMIDE 100MG · CAPSULE · ORAL
ZONISAMIDEPrescription
ZONISAMIDE 25MG · CAPSULE · ORAL
Approval history
2023-03-08Labeling · Supplement 6 · standardAP
2023-03-08Labeling · Supplement 7 · standardAP
2012-05-30Labeling · Supplement 4AP
2010-09-29Labeling · Supplement 3AP
2010-02-26Labeling · Supplement 2AP
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.