Product Details for: tecelra Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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| Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
|---|---|---|---|---|---|---|---|
| 001 | Suspension | Intravenous | 2.68 x 10^9 to 10 x 10^9 CELL/ML | Bag | 351(a) | tecelra | Rx |
Proper Name
afamitresgene autoleucel
BLA Number
125789
Applicant
Adaptimmune LLC
Original Approval Date
August 1, 2024
Date of First Licensure
August 1, 2024