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Fluorescein
Ak-fluor, Altafluor Benox, Fluorescite (fluorescein) is a small molecule pharmaceutical. Fluorescein was first approved as Funduscein-25 on 1982-01-01.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Ak-fluor, Fluorescite (discontinued: Funduscein)
Combinations
Altafluor benox
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Fluorescein sodium
Tradename
Company
Number
Date
Products
AK-FLUOR 10%AkornN-022186 RX2008-08-08
1 products, RLD
AK-FLUOR 25%AkornN-022186 RX2008-08-08
1 products, RLD, RS
FLUORESCITEAlcon ResearchN-021980 RX2006-03-28
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ak-fluorNew Drug Application2020-10-08
fluorescein sodium and benoxinate hydrochlorideNDA authorized generic2023-03-16
fluoresciteNew Drug Application2020-11-09
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
30 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital adrenal hyperplasiaD000312E25.0—1—1—2
Vasovagal syncopeD019462R55——11—2
Orthostatic hypotensionD007024I95.11——1—2
HypertensionD006973EFO_0000537I10———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Septic shockD012772A48.3—24——5
Wounds and injuriesD014947T14.8——1——1
Traumatic brain injuriesD000070642S06——1——1
PneumoniaD011014EFO_0003106J18——1——1
Adrenal insufficiencyD000309——1——1
Covid-19D000086382U07.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—21———3
Parkinson diseaseD010300EFO_0002508G2011———2
MelanomaD008545—1———1
Ovarian hyperstimulation syndromeD016471—1———1
Critical illnessD016638—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sensorineural hearing lossD006319HP_0000407H90.51————1
DepressionD003863F33.91————1
Multiple system atrophyD0195781————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E10————11
IndividualityD007206————11
NephrolithiasisD053040N20.0————11
Renal tubular acidosisD000141N25.89————11
Borderline personality disorderD001883HP_0012076F60.3————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—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C1C=CC2C(=C1)Oc1cc(O)ccc1C21OC(=O)c2ccccc21
Identifiers
PDB—
CAS-ID2321-07-5
RxCUI25138
ChEMBL IDCHEMBL4297067
ChEBI ID—
PubChem CID16850
DrugBankDB00693
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 231,731 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,074 adverse events reported
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