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FLUORESCEIN SODIUM

ANDA

FLUORESCEIN SODIUM | A215709 | NEXUS PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AK-FLUOR 10%(TE code: AP)

API Supply Chain7 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

DELMAR CHEMICALS INCFLUORESCEIN

DMF 187912005

ABBEY COLOR INCFLUORESCEIN USP

DMF 197772006

ICROM SRLFLUORESCEIN SODIUM

DMF 291442015

MACSEN DRUGSFLUORESCEIN SODIUM USP

DMF 389602023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFLUORESCEIN SODIUM

DMF 393342023

ICROM SRLFLUORESCEIN SODIUM

DMF 393622024

APICORE LLCFLUORESCEIN SODIUM USP

DMF 409712024

EASTMAN KODAK COInactiveFLUORESCEIN

DMF 90941991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Sep 25, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Sep 25, 2023

Change History (1)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Nexus discontinued Fluorescein Sodium (NDA 215709, supplemental application 002), changing the product type from prescription to discontinued.

Old: RX

New: DISCN