Details for New Drug Application (NDA): 220046
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NDA 220046 describes FLUORESCEIN SODIUM, which is a drug marketed by Bpi Labs, Nexus, and Bausch Lomb Ireland, and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the FLUORESCEIN SODIUM profile page.
The generic ingredient in FLUORESCEIN SODIUM is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
The generic ingredient in FLUORESCEIN SODIUM is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
Summary for 220046
| Tradename: | FLUORESCEIN SODIUM |
| Applicant: | Bpi Labs |
| Ingredient: | fluorescein sodium |
| Patents: | 0 |
Pharmacology for NDA: 220046
| Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for 220046
Suppliers and Packaging for NDA: 220046
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 220046 | ANDA | BPI Labs LLC | 54288-179 | 54288-179-10 | 10 VIAL, GLASS in 1 CARTON (54288-179-10) / 5 mL in 1 VIAL, GLASS (54288-179-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
| Approval Date: | Apr 30, 2026 | TE: | AP | RLD: | No | ||||
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