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Last Updated: November 2, 2024

FLUORESCEIN SODIUM - Generic Drug Details


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What are the generic drug sources for fluorescein sodium and what is the scope of patent protection?

Fluorescein sodium is the generic ingredient in five branded drugs marketed by Novartis, Long Grove Pharms, Nexus Pharms, and Alcon Labs Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for fluorescein sodium. Four suppliers are listed for this compound.

Summary for FLUORESCEIN SODIUM
US Patents:0
Tradenames:5
Applicants:4
NDAs:4
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 44
Patent Applications: 1,425
What excipients (inactive ingredients) are in FLUORESCEIN SODIUM?FLUORESCEIN SODIUM excipients list
DailyMed Link:FLUORESCEIN SODIUM at DailyMed
Recent Clinical Trials for FLUORESCEIN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPhase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolEarly Phase 1
Seoul National University Bundang HospitalPhase 4

See all FLUORESCEIN SODIUM clinical trials

Pharmacology for FLUORESCEIN SODIUM
Drug ClassDiagnostic Dye
Mechanism of ActionDyes
Medical Subject Heading (MeSH) Categories for FLUORESCEIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for FLUORESCEIN SODIUM

US Patents and Regulatory Information for FLUORESCEIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Long Grove Pharms AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-001 Aug 8, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc FLUORESCITE fluorescein sodium INJECTABLE;INTRAVENOUS 021980-001 Mar 28, 2006 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Long Grove Pharms AK-FLUOR 25% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-002 Aug 8, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis FUNDUSCEIN-25 fluorescein sodium INJECTABLE;INJECTION 017869-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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