alirocumab Auto-Injector
- Brand(s)
- Praluent
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sanofi-Aventis U.S. Llc (2015-07-24)
- Oldest Current Product
- 2015-07-24
- License(s)
- BLA
- RxNORM
- AUTO-INJECTOR\ALIROCUMAB
- SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\ALIROCUMAB
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\ALIROCUMAB
product(s) by strength(s)
1 ml alirocumab 150 mg/ml auto-injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000245902 | Praluent | BLA | Sanofi-Aventis U.S. Llc | 2015-07-24 | ALIROCUMAB | SUBCUTANEOUS | INJECTION, SOLUTION | 125559 | 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 |
1 ml alirocumab 75 mg/ml auto-injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000245901 | Praluent | BLA | Sanofi-Aventis U.S. Llc | 2015-07-24 | ALIROCUMAB | SUBCUTANEOUS | INJECTION, SOLUTION | 125559 | 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125559 | alirocumab Application | 2015-07-24 | Praluent | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 (view SPL) | These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT (alirocumab) injection, for subcutaneous useInitial U.S. Approval: 2015 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2015-07-24 | 1 | 000245901, 000245902, 000245903, 000245904 | alirocumab Prefilled Syringe |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII