FdaApplication

ANDA 220919

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Identifiers

Properties

PropertyValue
applicant_nameQILU PHARMACEUTICAL HAINAN CO LTD
application_typeANDA
approval_date2026-08-31

Products (1)

ProductActive ingredientStrengthDosage form
DIFELIKEFALIN ACETATEDIFELIKEFALIN ACETATEEQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)SOLUTION;INTRAVENOUS

1 product