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Application 761180
- Type
- BLA
- Sponsor
- LEO PHARMA AS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADBRY | TRALOKINUMAB | INJECTABLE;INJECTION | 150MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50222-346 | Adbry | tralokinumab-ldrm | LEO Pharma Inc. | BLA | Current |
| 50222-346 | Adbry | tralokinumab-ldrm | LEO Pharma Inc. | BLA | Current |
| 50222-346 | Adbry | tralokinumab-ldrm | LEO Pharma Inc. | BLA | Current |
| 50222-346 | Adbry | tralokinumab-ldrm | LEO Pharma Inc. | BLA | Current |
| 50222-346 | Adbry | tralokinumab-ldrm | LEO Pharma Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84450 | SUPPL | 2025-12-18 |
| 84419 | SUPPL | 2025-12-15 |
| 78784 | SUPPL | 2024-06-13 |
| 78781 | SUPPL | 2024-06-13 |
| 76859 | SUPPL | 2023-12-15 |
| 76848 | SUPPL | 2023-12-15 |
| 74429 | SUPPL | 2023-06-05 |
| 71653 | SUPPL | 2022-07-28 |
| 69964 | ORIG | 2022-01-25 |
| 69793 | ORIG | 2021-12-28 |
| 69791 | ORIG | 2021-12-28 |