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FDA ANDA · ANDA203052
LEVETIRACETAM
levetiracetam oral
Sponsor: HETERO LABS LTD III
APPLICATION
ANDA203052
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-28
LATEST ACTION
2025-02-25
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2025-02-25Labeling · Supplement 17 · standardAP
2025-02-25Labeling · Supplement 18 · standardAP
2020-07-28Labeling · Supplement 12 · standardAP
2020-07-28Labeling · Supplement 10 · standardAP
2020-07-28Labeling · Supplement 9 · standardAP
2020-07-28Labeling · Supplement 1 · standardAP
2020-07-28Labeling · Supplement 4 · standardAP
2020-07-28Labeling · Supplement 2 · standardAP
2013-02-28UNKNOWN · 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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