FdaApplication

ANDA 218364

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Identifiers

Properties

PropertyValue
applicant_nameMYLAN LABORATORIES LTD
application_typeANDA
approval_date2026-05-08

Products (3)

ProductActive ingredientStrengthDosage form
LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE;INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE;INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE;INTRAVENOUS

3 products