Overview
A phthalic indicator dye that appears yellow-green in normal tear film and bright green in a more alkaline medium, such as the aqueous humor, and is used therapeutically as a diagnostic aid in corneal injuries and corneal trauma. It has been approved by FDA for use in externally applied drugs and cosmetics. (From Merck Index, 12th ed; American Medical Association Drug Evaluations; 1995, p2275)
Indication
For diagnostic imaging. Primarily indicated in diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature.
Associated Conditions
- Peritoneal dialysis therapy
- Pneumocystis Jirovecii Pneumonia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/13 | Phase 2 | Recruiting | |||
2023/09/26 | Phase 2 | ENROLLING_BY_INVITATION | |||
2022/12/23 | Phase 4 | Completed | |||
2020/04/17 | Phase 2 | Completed | |||
2019/08/28 | Phase 1 | Completed | UpTru Inc. | ||
2019/07/12 | Phase 2 | Active, not recruiting | Aditya Kaza | ||
2019/01/30 | Not Applicable | Recruiting | |||
2018/11/23 | Not Applicable | Terminated | |||
2017/09/29 | Early Phase 1 | Completed | |||
2017/08/10 | Phase 4 | Suspended |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | 24208-734 | OPHTHALMIC | 2.6 mg in 1 mL | 8/31/2022 | |
| A-S Medication Solutions | 50090-4535 | INTRAVENOUS | 100 mg in 1 mL | 8/15/2016 | |
| Altaire Pharmaceuticals Inc. | 59390-205 | OPHTHALMIC | 2.5 mg in 1 mL | 11/1/2022 | |
| Akorn | 17478-403 | OPHTHALMIC | 0.6 mg in 1 1 | 3/22/2012 | |
| Oceanside Pharmaceuticals | 68682-732 | OPHTHALMIC | 2.6 mg in 1 mL | 3/19/2020 | |
| Akorn | 17478-253 | INTRAVENOUS | 100 mg in 1 mL | 8/15/2016 | |
| Akorn | 17478-404 | OPHTHALMIC | 1 mg in 1 1 | 3/22/2012 | |
| Nexus Pharmaceuticals LLC | 14789-123 | INTRAVENOUS | 250 mg in 1 mL | 10/25/2023 | |
| Bausch & Lomb Americas Inc. | 82260-734 | OPHTHALMIC | 2.6 mg in 1 mL | 3/16/2023 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1533 | INTRAVENOUS | 100 mg in 1 mL | 8/8/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RETINOFLUOR fluorescein sodium 10% injection 500mg/5mL vial | 121873 | Medicine | A | 10/22/2007 | |
| FLUORESCEIN SERB fluorescein sodium 500mg/5mL injection solution ampoule | 124565 | Medicine | A | 2/13/2007 | |
| RETINOFLUOR fluorescein sodium 25% injection | 23138 | Medicine | A | 10/14/1991 | |
| Minims Fluorescein Sodium 2% 20mg/mL Eye Drops tube | 32268 | Medicine | A | 10/30/1991 | |
| MINIMS lidocaine hydrochloride monohydrate 4% and fluorescein sodium 0.25% eye drops tube | 32272 | Medicine | A | 10/30/1991 | |
| MINIMS FLUORESCEIN SODIUM 1% 10mg/mL eye drops tube | 32228 | Medicine | A | 10/30/1991 | |
| FLUORESCITE fluorescein 10% 500mg/5mL (as sodium) injection vial | 124267 | Medicine | A | 4/12/2006 | |
| RETINOFLUOR fluorescein sodium 10% injection 1g/10mL vial | 23130 | Medicine | A | 10/14/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FLUORETS (FLUORESCEIN OPHTHALMIC STRIPS) | dioptic pharmaceuticals inc | 02026252 | Strip - Ophthalmic | 1 MG | 12/31/1994 |
| FLUORESCEIN | pharma stulln inc. | 02027097 | Solution - Intravenous | 250 MG / ML | 12/31/1994 |
| ODAN-FLUORESCEIN | odan laboratories ltd | 00622869 | Solution - Intravenous | 100 MG / ML | 12/31/1984 |
| ODAN-FLUORESCEIN | odan laboratories ltd | 00622877 | Liquid - Intravenous | 250 MG / ML | 12/31/1985 |
| MINIMS FLUORESCEIN SODIUM | bausch & lomb inc | 02148390 | Drops - Ophthalmic | 2 % / W/V | 12/31/1995 |
| BIO GLO | white ophthalmic services & supply co ltd | 02317281 | Strip - Ophthalmic | 1 MG | 1/28/2009 |
| FLUORESCEIN | pharma stulln inc. | 02027089 | Solution - Intravenous | 100 MG / ML | 12/31/1994 |
| ODAN-FLUORETS | odan laboratories ltd | 00687812 | Strip - Ophthalmic | 1 MG | 12/31/1986 |
| FLUORETS - STP OPH 1MG | chauvin pharmaceuticals limited | 02179539 | Strip - Ophthalmic | 1 MG | 11/1/1996 |
| FLUOROX | white ophthalmic services & supply co ltd | 02354993 | Solution - Ophthalmic | 0.25 % | 11/28/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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