Application 761103
- Type
- BLA
- Sponsor
- PFIZER INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761103 | Ruxience | rituximab-pvvr | 351(k) Biosimilar | Rx | 2026-08-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RUXIENCE | RITUXIMAB-PVVR | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | No | No |
| 002 | RUXIENCE | RITUXIMAB-PVVR | INJECTABLE;INJECTION | 500MG/50ML(10MG/ML) | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 6 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0069-0238 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0238 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0238 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0249 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0249 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0249 | Ruxience | rituximab-pvvr | Pfizer Laboratories Div Pfizer Inc | BLA | Current |