FdaApplication

ANDA 203279

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Identifiers

Properties

PropertyValue
applicant_nameAPOTEX INC
application_typeANDA
approval_date2026-01-26

Products (3)

ProductActive ingredientStrengthDosage form
PALIPERIDONEPALIPERIDONE6MGTABLET, EXTENDED RELEASE;ORAL
PALIPERIDONEPALIPERIDONE3MGTABLET, EXTENDED RELEASE;ORAL
PALIPERIDONEPALIPERIDONE9MGTABLET, EXTENDED RELEASE;ORAL

3 products