APPLICATION
ANDA077869
TYPE
ANDA
ORIGINAL APPROVAL
2006-05-31
LATEST ACTION
2022-05-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZONISAMIDEPrescription
ZONISAMIDE 25MG · CAPSULE · ORAL
ZONISAMIDEPrescription
ZONISAMIDE 50MG · CAPSULE · ORAL
ZONISAMIDEPrescription
ZONISAMIDE 100MG · CAPSULE · ORAL
Approval history
2022-05-25Labeling · Supplement 14 · standardAP
2020-03-12Labeling · Supplement 9 · standardAP
2016-02-26Labeling · Supplement 7 · standardAP
2015-06-13Labeling · Supplement 3 · standardAP
2012-06-07Labeling · Supplement 2AP
2010-03-31Labeling · 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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