Details for New Drug Application (NDA): 219868
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NDA 219868 describes FERABRIGHT, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. Additional details are available on the FERABRIGHT profile page.
The generic ingredient in FERABRIGHT is ferumoxytol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.
The generic ingredient in FERABRIGHT is ferumoxytol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.
Summary for 219868
| Tradename: | FERABRIGHT |
| Applicant: | Covis |
| Ingredient: | ferumoxytol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERABRIGHT | ferumoxytol | SOLUTION;INTRAVENOUS | 219868 | NDA | Azurity Pharmaceuticals, Inc. | 24338-310 | 24338-310-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| FERABRIGHT | ferumoxytol | SOLUTION;INTRAVENOUS | 219868 | NDA | Azurity Pharmaceuticals, Inc. | 24338-510 | 24338-510-17 | 1 VIAL, SINGLE-DOSE in 1 CARTON (24338-510-17) / 17 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 300MG IRON/10ML (EQ 30MG IRON/ML) | ||||
| Approval Date: | Oct 16, 2025 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | ||||
| Approval Date: | Oct 16, 2025 | TE: | RLD: | Yes | |||||
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