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DIFELIKEFALIN ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: QILU PHARM HAINAN · Approved 2026-08-31

Drug application

FDA Application #

ANDA220919

Application type

Abbreviated New Drug Application (Generic)

Brand name

DIFELIKEFALIN ACETATE

Generic name

Difelikefalin Acetate

Active ingredients

DIFELIKEFALIN ACETATE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

QILU PHARM HAINAN

First approval

2026-08-31

Source

Authoritative

Drugs@FDA application overview

Machine

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