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FDA ANDA · ANDA212688
LEVETIRACETAM EXTENDED-RELEASE
levetiracetam
Sponsor: OVERSEAS
APPLICATION
ANDA212688
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-11
LATEST ACTION
2022-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-07-20Labeling · Supplement 2 · standardAP
2020-06-11UNKNOWN · Original · standardAP
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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