Details for New Drug Application (NDA): 213792
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NDA 213792 describes IOFLUPANE I-123, which is a drug marketed by Curium and is included in one NDA. It is available from one supplier. Additional details are available on the IOFLUPANE I-123 profile page.
The generic ingredient in IOFLUPANE I-123 is ioflupane i-123. Two suppliers are listed for this compound. Additional details are available on the ioflupane i-123 profile page.
The generic ingredient in IOFLUPANE I-123 is ioflupane i-123. Two suppliers are listed for this compound. Additional details are available on the ioflupane i-123 profile page.
Summary for 213792
| Tradename: | IOFLUPANE I-123 |
| Applicant: | Curium |
| Ingredient: | ioflupane i-123 |
| Patents: | 0 |
Pharmacology for NDA: 213792
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 213792
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IOFLUPANE I-123 | ioflupane i-123 | SOLUTION;INTRAVENOUS | 213792 | ANDA | Curium US LLC | 69945-166 | 69945-166-05 | 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5mCi/2.5ML (2mCi/ML) | ||||
| Approval Date: | Mar 30, 2022 | TE: | AP | RLD: | No | ||||
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