- Brand(s)
- Synagis
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Medimmune, Llc (2014-03-27)
- Oldest Current Product
- 1998-06-19
- License(s)
- BLA
- RxNORM
- INJECTION\PALIVIZUMAB
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\PALIVIZUMAB
- SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\PALIVIZUMAB
product(s) by strength(s)
0.5 ml palivizumab 100 mg/ml injection
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 605744114 | Synagis | BLA | Medimmune, Llc | 1999-12-09 | PALIVIZUMAB | INTRAMUSCULAR | INJECTION, SOLUTION | 103770 | 8e35c4c8-bf56-458f-a73c-8f5733829788 |
1 ml palivizumab 100 mg/ml injection
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 605744113 | Synagis | BLA | Medimmune, Llc | 1998-06-19 | PALIVIZUMAB | INTRAMUSCULAR | INJECTION, SOLUTION | 103770 | 8e35c4c8-bf56-458f-a73c-8f5733829788 |
| # | id | title | approved | tradenames | fda division |
|---|
| 1 | 103770 | palivizumab Application | 1998-06-19 | Synagis | CDER |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | 8e35c4c8-bf56-458f-a73c-8f5733829788 (view SPL) | These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS. SYNAGIS (palivizumab) injection , for intramuscular use Initial U.S. Approval: 1998 | prescription | Human Prescription | Medimmune, Llc | 2014-03-27 | 28 | 605744113, 605744114 |