rituximab Injection
- Brand(s)
- Rituxan
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Genentech, Inc. (2015-10-14)
- Oldest Current Product
- 1997-11-26
- License(s)
- BLA
- RxNORM
- INJECTION\RITUXIMAB
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\RITUXIMAB
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\RITUXIMAB
product(s) by strength(s)
50 ml rituximab 10 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 502420053 | Rituxan | BLA | Genentech, Inc. | 1997-11-26 | RITUXIMAB | INTRAVENOUS | INJECTION, SOLUTION | 103705 | b172773b-3905-4a1c-ad95-bab4b6126563 |
10 ml rituximab 10 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 502420051 | Rituxan | BLA | Genentech, Inc. | 1997-11-26 | RITUXIMAB | INTRAVENOUS | INJECTION, SOLUTION | 103705 | b172773b-3905-4a1c-ad95-bab4b6126563 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 103705 | rituximab Application | 1997-11-26 | Rituxan | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | b172773b-3905-4a1c-ad95-bab4b6126563 (view SPL) | These highlights do not include all the information needed to use RITUXAN safely and effectively. See full prescribing information for RITUXAN. RITUXAN (rituximab) injection, for intravenous use Initial U.S. Approval: 1997 | prescription | Human Prescription | Genentech, Inc. | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2015-10-14 | 14 | 502420051, 502420053 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII