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FDA ANDA · ANDA207160
LEVETIRACETAM
levetiracetam in sodium chloride
Sponsor: EUGIA PHARMA
APPLICATION
ANDA207160
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-04
LATEST ACTION
2025-03-10
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 1GM/100ML (10MG/ML) · INJECTABLE · INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 1.5GM/100ML (15MG/ML) · INJECTABLE · INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 500MG/100ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-03-10Labeling · Supplement 9 · standardAP
2023-05-23Labeling · Supplement 5 · standardAP
2020-07-11Labeling · Supplement 3 · standardAP
2020-07-11Labeling · Supplement 4 · standardAP
2020-07-11Labeling · Supplement 2 · standardAP
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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