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FDA ANDA · ANDA202958

LEVETIRACETAM

Sponsor: APOTEX

APPLICATION
ANDA202958
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-25
LATEST ACTION
2024-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

LEVETIRACETAMDiscontinued
LEVETIRACETAM 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-10-09Labeling · Supplement 9 · standardAP
2024-10-09Labeling · Supplement 8 · standardAP
2024-04-23Labeling · Supplement 7 · standardAP
2020-09-10Labeling · Supplement 5 · standardAP
2020-09-10Labeling · Supplement 3 · standardAP
2020-09-10Labeling · Supplement 1 · standardAP
2020-09-10Labeling · Supplement 6 · standardAP
2020-09-10Labeling · Supplement 4 · standardAP
2020-09-10Labeling · Supplement 2 · standardAP
2015-02-25UNKNOWN · OriginalLabelAP
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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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