APPLICATION
ANDA201157
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-04
LATEST ACTION
2024-11-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2024-11-13Labeling · Supplement 12 · standardAP
2023-11-21Labeling · Supplement 11 · standardAP
2023-05-22Labeling · Supplement 8 · standardAP
2020-07-08Labeling · Supplement 6 · standardAP
2020-07-08Labeling · Supplement 4 · standardAP
2020-07-08Labeling · Supplement 5 · standardAP
2020-07-08Labeling · Supplement 1 · standardAP
2015-06-04Not Applicable · OriginalAP
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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