Application 761073
- Type
- BLA
- Sponsor
- AMGEN INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761073 | Kanjinti | trastuzumab-anns | 351(k) Biosimilar | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KANJINTI | TRASTUZUMAB-ANNS | INJECTABLE;INJECTION | 420MG | No | No |
| 002 | KANJINTI | TRASTUZUMAB-ANNS | VIAL;SINGLE-DOSE | 150MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kanjinti | TRASTUZUMAB-ANNS | Amgen, Inc | 9a94f5b2-b84e-4987-8ea1-c4346db5a5fa | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | BLA761073 55513-141 55513-132 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-132 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-141 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-141 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-141 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |
| 55513-141 | Kanjinti | trastuzumab-anns | Amgen Inc | BLA | Current |