FdaApplication

ANDA 220447

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Identifiers

Properties

PropertyValue
applicant_nameZYDUS PHARMACEUTICALS USA INC
application_typeANDA
approval_date2026-07-21

Products (2)

ProductActive ingredientStrengthDosage form
FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE;ORAL
FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE;ORAL

2 products