Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220919
Company: QILU PHARM HAINAN

Products on ANDA 220919

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFELIKEFALIN ACETATE	DIFELIKEFALIN ACETATE	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220919

DIFELIKEFALIN ACETATE

SOLUTION;INTRAVENOUS; EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFELIKEFALIN ACETATE	DIFELIKEFALIN ACETATE	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220919	QILU PHARM HAINAN
KORSUVA	DIFELIKEFALIN ACETATE	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214916	VIFOR INTL