Application 761106
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761106 | Herceptin Hylecta | trastuzumab and hyaluronidase-oysk | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HERCEPTIN HYLECTA | TRASTUZUMAB; HYALURONIDASE-OYSK | INJECTABLE;SUBCUTANEOUS | 600MG;10000UNITS | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 5 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85986 | SUPPL | 2026-05-19 |
| 85975 | SUPPL | 2026-05-19 |
| 78852 | SUPPL | 2024-06-20 |
| 78831 | SUPPL | 2024-06-20 |
| 60577 | ORIG | 2019-10-17 |
| 57864 | ORIG | 2019-03-01 |
| 57834 | ORIG | 2019-02-28 |