Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215709
Company: NEXUS

Products on ANDA 215709

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	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215709

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215709Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215709

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	215709	NEXUS
FLUORESCITE	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021980	ALCON LABS INC

INJECTABLE;INTRAVENOUS; EQ 500MG BASE/2ML (EQ 250MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215709	NEXUS