APPLICATION
ANDA077636
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 25MG · CAPSULE · ORAL
ZONISAMIDEPrescription
ZONISAMIDE 100MG · CAPSULE · ORAL
Approval history
2023-03-08Labeling · Supplement 5 · standardAP
2023-03-08Labeling · Supplement 6 · standardAP
2010-08-13REMS · Supplement 3AP
2006-07-27Labeling · Supplement 2AP
2006-07-27Manufacturing (CMC) · 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.
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