APPLICATION
ANDA078774
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-10
LATEST ACTION
2014-12-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2014-12-11Labeling · Supplement 8 · standardAP
2014-12-11Labeling · Supplement 6 · standardAP
2014-12-11Labeling · Supplement 7 · standardAP
2014-12-11Labeling · Supplement 5 · standardAP
2010-12-15Labeling · Supplement 4AP
2009-08-24Labeling · 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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