Application 761106
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761106 | Herceptin Hylecta | trastuzumab and hyaluronidase-oysk | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HERCEPTIN HYLECTA | TRASTUZUMAB; HYALURONIDASE-OYSK | INJECTABLE;SUBCUTANEOUS | 600MG;10000UNITS | 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 |
|---|---|---|---|---|---|---|
| Herceptin Hylecta | TRASTUZUMAB AND HYALURONIDASE-OYSK | Genentech, Inc. | ebf30894-41cf-480c-8bc3-56f592a13813 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | BLA761106 50242-077 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-077 | Herceptin Hylecta | Trastuzumab and hyaluronidase-oysk | Genentech, Inc. | BLA | Current |
| 50242-077 | Herceptin Hylecta | Trastuzumab and hyaluronidase-oysk | Genentech, Inc. | BLA | Current |
| 50242-077 | Herceptin Hylecta | Trastuzumab and hyaluronidase-oysk | Genentech, Inc. | BLA | Current |
| 50242-077 | Herceptin Hylecta | Trastuzumab and Hyaluronidase-oysk | Genentech, Inc. | BLA | Current |
| 50242-077 | Herceptin Hylecta | Trastuzumab and hyaluronidase-oysk | Genentech, Inc. | BLA | Current |