Product Details for: Imdelltra

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1MG
Single-Dose Vial
351(a)
Imdelltra
Rx
002
Injection
Intravenous
10MG
Single-Dose Vial
351(a)
Imdelltra
Rx
Proper Name
tarlatamab-dlle
BLA Number
761344
Applicant
Amgen Inc.
Original Approval Date
May 16, 2024
Date of First Licensure