Details for New Drug Application (NDA): 218525
NDA 218525 describes BEXLUTRY, 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 BEXLUTRY profile page.
The generic ingredient in BEXLUTRY is lutetium lu-177 dotatate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lutetium lu-177 dotatate profile page.
The generic ingredient in BEXLUTRY is lutetium lu-177 dotatate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lutetium lu-177 dotatate profile page.
Summary for 218525
| Tradename: | BEXLUTRY |
| Applicant: | Curium |
| Ingredient: | lutetium lu-177 dotatate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218525
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BEXLUTRY | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 218525 | NDA | Curium US LLC | 69945-177 | 69945-177-01 | 20 mL in 1 VIAL, SINGLE-DOSE (69945-177-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10mCi/ML | ||||
| Approval Date: | Sep 14, 2026 | TE: | RLD: | Yes | |||||
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