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FDA ANDA · ANDA215069

LEVETIRACETAM

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA215069
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-11
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL

Approval history

2024-11-26Labeling · Supplement 5 · standardAP
2024-11-26Labeling · Supplement 6 · standardAP
2023-01-05Labeling · Supplement 2 · standardAP
2022-05-27UNKNOWN · Original · standard — Letter ↗AP
2021-06-11UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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