nivolumab Injection
- Brand(s)
- Opdivo
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- E.R. Squibb & Sons, L.L.C. (2015-10-09)
- Oldest Current Product
- 2014-12-22
- License(s)
- BLA
- RxNORM
- INJECTION\NIVOLUMAB
- SPL Active
- INTRAVENOUS\INJECTION\NIVOLUMAB
- SPL Moiety
- INTRAVENOUS\INJECTION\NIVOLUMAB
product(s) by strength(s)
4 ml nivolumab 10 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000033772 | Opdivo | BLA | E.R. Squibb & Sons, L.L.C. | 2014-12-22 | NIVOLUMAB | INTRAVENOUS | INJECTION | 125554 | f570b9c4-6846-4de2-abfa-4d0a4ae4e394 |
10 ml nivolumab 10 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000033774 | Opdivo | BLA | E.R. Squibb & Sons, L.L.C. | 2014-12-22 | NIVOLUMAB | INTRAVENOUS | INJECTION | 125554 | f570b9c4-6846-4de2-abfa-4d0a4ae4e394 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125554 | nivolumab Application | 2014-12-22 | Opdivo | CDER |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | f570b9c4-6846-4de2-abfa-4d0a4ae4e394 (view SPL) | These highlights do not include all the information needed to use OPDIVO safely and effectively. See full prescribing information for OPDIVO. OPDIVO (nivolumab) injection, for intravenous useInitial U.S. Approval: 2014 | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2015-10-09 | 3 | 000033772, 000033774 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII