FdaApplication

ANDA 205057

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Identifiers

Properties

PropertyValue
applicant_nameHIKMA PHARMS
application_typeANDA
approval_date2026-02-10

Products (3)

ProductActive ingredientStrengthDosage form
TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET;ORAL
TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET;ORAL
TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET;ORAL

3 products