Application 761106
- Type
- BLA
- Sponsor
- GENENTECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HERCEPTIN HYLECTA | TRASTUZUMAB; HYALURONIDASE-OYSK | INJECTABLE;SUBCUTANEOUS | 600MG;10000UNITS | No | No |
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 |