APPLICATION
ANDA077625
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-16
LATEST ACTION
2022-05-25
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
2022-05-25Labeling · Supplement 8 · standardAP
2020-03-12Labeling · Supplement 7 · standardAP
2012-05-30Labeling · Supplement 6AP
2012-05-30Labeling · Supplement 5AP
2011-09-27REMS · Supplement 4AP
2010-08-11REMS · Supplement 3AP
2010-08-11Labeling · 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.
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