Details for New Drug Application (NDA): 218651
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NDA 218651 describes FLUORESCEIN SODIUM, which is a drug marketed by Bpi Labs, Nexus, Zydus Lifesciences, and Bausch Lomb Ireland, and is included in four NDAs. It is available from four 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 218651
| Tradename: | FLUORESCEIN SODIUM |
| Applicant: | Zydus Lifesciences |
| Ingredient: | fluorescein sodium |
| Patents: | 0 |
Pharmacology for NDA: 218651
| Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for 218651
Suppliers and Packaging for NDA: 218651
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 218651 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-2045 | 70710-2045-9 | 12 VIAL, SINGLE-DOSE in 1 CARTON (70710-2045-9) / 5 mL in 1 VIAL, SINGLE-DOSE (70710-2045-1) |
| FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 218651 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-2046 | 70710-2046-9 | 12 VIAL, SINGLE-DOSE in 1 CARTON (70710-2046-9) / 2 mL in 1 VIAL, SINGLE-DOSE (70710-2046-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
| Approval Date: | Jun 1, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/2ML (EQ 250MG BASE/ML) | ||||
| Approval Date: | Jun 1, 2026 | TE: | RLD: | No | |||||
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