Details for New Drug Application (NDA): 215709
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NDA 215709 describes FLUORESCEIN SODIUM, which is a drug marketed by Nexus Pharms and Bausch Lomb Ireland and is included in two NDAs. It is available from one supplier. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
Summary for 215709
| Tradename: | FLUORESCEIN SODIUM |
| Applicant: | Nexus Pharms |
| Ingredient: | fluorescein sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215709
| Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for 215709
Suppliers and Packaging for NDA: 215709
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 215709 | ANDA | Nexus Pharmaceuticals LLC | 14789-122 | 14789-122-05 | 10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07) |
| FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 215709 | ANDA | Nexus Pharmaceuticals LLC | 14789-123 | 14789-123-05 | 10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
| Approval Date: | Sep 25, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/2ML (EQ 250MG BASE/ML) | ||||
| Approval Date: | Sep 25, 2023 | TE: | AP | RLD: | No | ||||
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