daratumumab Injection
- Brand(s)
- Darzalex
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Janssen Biotech, Inc. (2015-11-05)
- Oldest Current Product
- 2015-11-16
- License(s)
- BLA
- RxNORM
- INJECTION\DARATUMUMAB
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DARATUMUMAB
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DARATUMUMAB
product(s) by strength(s)
5 ml daratumumab 20 mg/ml injection
product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 578940502 | Darzalex | BLA | Janssen Biotech, Inc. | 2015-11-16 | DARATUMUMAB | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | 761036 | a4d0efe9-5e54-467e-9eb4-56fa7d53b60b |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | a4d0efe9-5e54-467e-9eb4-56fa7d53b60b (view SPL) | These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX (daratumumab) injection, for intravenous useInitial U.S. Approval 2015 | prescription | Human Prescription | Janssen Biotech, Inc. | ANALYSIS, MANUFACTURE, PACK | 2015-11-05 | 2 | 578940502 |