ipilimumab Injection
- Brand(s)
- Yervoy
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- E.R. Squibb & Sons, L.L.C. (2015-10-28)
- Oldest Current Product
- 2011-03-25
- License(s)
- BLA
- RxNORM
- INJECTION\IPILIMUMAB
- SPL Active
- INTRAVENOUS\INJECTION\IPILIMUMAB
- SPL Moiety
- INTRAVENOUS\INJECTION\IPILIMUMAB
product(s) by strength(s)
10 ml ipilimumab 5 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000032327 | Yervoy | BLA | E.R. Squibb & Sons, L.L.C. | 2011-03-25 | IPILIMUMAB | INTRAVENOUS | INJECTION | 125377 | 2265ef30-253e-11df-8a39-0800200c9a66 |
40 ml ipilimumab 5 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000032328 | Yervoy | BLA | E.R. Squibb & Sons, L.L.C. | 2011-03-25 | IPILIMUMAB | INTRAVENOUS | INJECTION | 125377 | 2265ef30-253e-11df-8a39-0800200c9a66 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125377 | ipilimumab Application | 2011-03-25 | Yervoy | CDER |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 2265ef30-253e-11df-8a39-0800200c9a66 (view SPL) | These highlights do not include all the information needed to use YERVOY safely and effectively. See full prescribing information for YERVOY. YERVOY (ipilimumab) injection, for intravenous use Initial U.S. Approval: 2011 | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2015-10-28 | 12 | 000032327, 000032328 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII