APPLICATION
ANDA079063
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2024-08-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2024-08-28Labeling · Supplement 23 · standardAP
2024-08-28Labeling · Supplement 15 · standardAP
2024-08-28Labeling · Supplement 26 · standardAP
2024-08-28Labeling · Supplement 32 · standardAP
2024-08-28Labeling · Supplement 16 · standardAP
2024-08-28Labeling · Supplement 30 · standardAP
2024-08-28Labeling · Supplement 22 · standardAP
2024-08-28Labeling · Supplement 19 · standardAP
2017-08-14Labeling · Supplement 20 · standardAP
2014-11-03Labeling · Supplement 13 · standardAP
2014-11-03Labeling · Supplement 8 · standardAP
2014-11-03Labeling · Supplement 10 · standardAP
2013-02-27Labeling · Supplement 6 · standardAP
2012-04-26Labeling · Supplement 4AP
2010-12-13Labeling · Supplement 2AP
2009-06-30Labeling · Supplement 1AP
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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