Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218651
Company: ZYDUS LIFESCIENCES

Products on ANDA 218651

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218651

FLUORESCEIN SODIUM

INJECTABLE;INTRAVENOUS; EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AK-FLUOR 10%	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022186	LONG GROVE PHARMS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	220046	BPI LABS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215709	NEXUS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	218651	ZYDUS LIFESCIENCES
FLUORESCITE	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021980	ALCON LABS INC