Skip to content
Application 761088
- Type
- BLA
- Sponsor
- CELLTRION INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRUXIMA | RITUXIMAB-ABBS | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | No | No |
| 002 | TRUXIMA | RITUXIMAB-ABBS | INJECTABLE;INJECTION | 500MG/50ML(10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-103 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |
| 63459-104 | Truxima | rituximab-abbs | Cephalon, Inc. | BLA | Current |