APPLICATION
ANDA079120
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-16
LATEST ACTION
2024-12-20
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2024-12-20Labeling · Supplement 15 · standardAP
2024-12-20Labeling · Supplement 21 · standardAP
2024-12-20Labeling · Supplement 18 · standardAP
2024-12-20Labeling · Supplement 22 · standardAP
2024-12-20Labeling · Supplement 14 · standardAP
2024-12-20Labeling · Supplement 12 · standardAP
2015-02-18Labeling · Supplement 8 · standardAP
2015-02-18Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 6AP
2015-02-18Labeling · Supplement 7 · standardAP
2015-02-18Labeling · Supplement 5AP
2010-04-26Labeling · Supplement 3AP
2010-02-25Labeling · Supplement 2AP
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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