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FUNDUSCEIN-25

NDA

FLUORESCEIN SODIUM | N017869 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ocular Manifestations of Granulomatosis With Polyangiitis.NCT07664709	—	Recruiting	Military Institute od Medicine National Research Institute	70	2024-03-01 → 2026-12-31
Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)NCT06413004	N/A	Recruiting	Magnus Simrén	200	2022-08-03 → 2027-12-01
Smartphone Screening for Eye Diseases NCT03076697	—	Completed	University of Michigan	550	2015-04-16 → 2019-05-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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.

Products (1)

#001 — 25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.