Details for New Drug Application (NDA): 206604
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NDA 206604 describes FERUMOXYTOL, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the FERUMOXYTOL profile page.
The generic ingredient in FERUMOXYTOL is ferumoxytol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.
The generic ingredient in FERUMOXYTOL is ferumoxytol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.
Summary for 206604
| Tradename: | FERUMOXYTOL |
| Applicant: | Sandoz |
| Ingredient: | ferumoxytol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206604
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERUMOXYTOL | ferumoxytol | SOLUTION;INTRAVENOUS | 206604 | ANDA | Sandoz Inc | 0781-3154 | 0781-3154-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE |
| FERUMOXYTOL | ferumoxytol | SOLUTION;INTRAVENOUS | 206604 | ANDA | Sandoz Inc | 0781-3154 | 0781-3154-95 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | ||||
| Approval Date: | Jan 15, 2021 | TE: | AB | RLD: | No | ||||
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