Application 761064
- 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 |
|---|
| 761064 | Rituxan Hycela | rituximab and hyaluronidase human | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) | SOLUTION;SUBCUTANEOUS | 1400MG and 23400UNITS/11.7ML | No | No |
| 002 | RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) | SOLUTION;SUBCUTANEOUS | 1600MG and 26800UNITS/13.4ML | 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 20 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase | Genentech, Inc. | BLA | Current |