Application 761091
- Type
- BLA
- Sponsor
- CELLTRION INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761091 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HERZUMA | TRASTUZUMAB-PKRB | INJECTABLE;INJECTION | 420MG | No | No |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HERZUMA | TRASTUZUMAB | Cephalon, Inc. | ae71c003-883a-4cd8-ad50-e8cc9a54e971 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | BLA761091 63459-303 63459-305 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | trastuzumab | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |