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Drug ReportsFluorescein
Fluorescein
Ak-fluor, Altafluor Benox, Fluorescein, Fluorescite (fluorescein) is a small molecule pharmaceutical. Fluorescein was first approved as Funduscein-25 on 1982-01-01.
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Events Timeline
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1M
3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Ak-fluor, Fluorescein, Fluorescite (discontinued: Funduscein)
Combinations
Altafluor benox, Fluorescein benoxinate
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorescein sodium
Tradename
Company
Number
Date
Products
FLUORESCITEAlcon ResearchN-021980 RX2006-03-28
1 products, RLD, RS
AK-FLUOR 10%Long Grove PharmaceuticalsN-022186 RX2008-08-08
1 products, RLD, RS
AK-FLUOR 25%Long Grove PharmaceuticalsN-022186 RX2008-08-08
1 products, RLD, RS
Show 1 discontinued
Benoxinate hydrochloride
+
Fluorescein sodium
Tradename
Company
Number
Date
Products
ALTAFLUOR BENOXAltaire PharmaceuticalsN-208582 RX2017-12-14
1 products, RLD, RS
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEBausch Health CompaniesN-211039 RX2020-03-09
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ak-fluorNew Drug Application2024-12-06
altafluorNew Drug Application2017-12-30
bioglounapproved drug other2024-01-01
c20h10na2o5 fluorescein sodium ophthalmic stripsunapproved drug other2024-10-01
dry eye testunapproved drug other2019-12-23
fluorecein sodium and proparacaine hydrochlorideunapproved drug other2014-07-17
fluoresceinANDA2023-10-25
fluorescein sodium and benoxinate hydrochlorideNew Drug Application2025-05-12
fluorescein sodium and proparacaine hydrochlorideunapproved drug other2022-10-28
fluoresciteNew Drug Application2023-12-14
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent
Expires
Flag
FDA Information
Benoxinate Hydrochloride / Fluorescein Sodium, Fluorescein Sodium And Benoxinate Hydrochloride, Bausch Lomb Ireland
102930472037-11-15DPU-2755
106321972037-11-15DPU-2755
108428722037-11-15U-3001
ATC Codes
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01J: Diagnostic agents, ophthamologic
— S01JA: Diagnostic, opthalmologic coloring agents
— S01JA01: Fluorescein
— S01JA51: Fluorescein, combinations
HCPCS
No data
Clinical
Clinical Trials
319 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperemiaD006940EFO_0003822H34.82——2——2
ErythemaD004890—L53.9——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dry eye syndromesD015352—H04.12————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluorescein
INN—
Description
Fluorescein (lactone form) is a xanthene dye that is highly fluorescent, detectable even when present in minute quantities. Used forensically to detect traces of blood, in analytical chemistry as an indicator in silver nitrate titrations and in microscopy. It has a role as a radioopaque medium and a fluorescent dye. It is a xanthene dye, a gamma-lactone, a polyphenol, an oxaspiro compound, a member of 2-benzofurans and an organic heteropentacyclic compound. It is functionally related to a fluorescein (acid form).
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
O=C1C=CC2C(=C1)Oc1cc(O)ccc1C21OC(=O)c2ccccc21
Identifiers
PDB—
CAS-ID2321-07-5
RxCUI—
ChEMBL IDCHEMBL4297067
ChEBI ID—
PubChem CID16850
DrugBankDB00693
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Fluorescein
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 162,551 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,019 adverse events reported
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