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FDA ANDA · ANDA090263

LEVETIRACETAM SOLUTION

levetiracetam

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA090263
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-03
LATEST ACTION
2026-04-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL

Approval history

2026-04-08Labeling · Supplement 17 · standardAP
2023-05-19Labeling · Supplement 15 · standardAP
2023-05-19Labeling · Supplement 13 · standardAP
2023-05-19Labeling · Supplement 11 · standardAP
2023-05-19Labeling · Supplement 14 · standardAP
2023-05-19Labeling · Supplement 12 · standardAP
2016-08-01Labeling · Supplement 9 · standardAP
2016-08-01Labeling · Supplement 10 · standardAP
2012-07-19Labeling · Supplement 7 · standardAP
2010-10-25Labeling · Supplement 3AP
2010-02-19Labeling · Supplement 2AP
2009-08-20Labeling · Supplement 1AP
2009-04-03Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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