- Brand(s)
- Corifact, Tretten
- Category(s)
- other
- SPL Type(s)
- Plasma Derivative
- Master SPL
- Csl Behring Gmbh (2015-09-30)
- Oldest Current Product
- 2011-02-17
- License(s)
- BLA
- RxNORM
- INJECTION\FACTOR XIII
product(s) by strength(s)
coagulation factor xiii a-subunit (recombinant) 1 unt injection
factor xiii, human 1 unt injection
# | id | title | approved | tradenames | fda division |
---|
1 | 125385 | Factor XIII Concentrate (Human) Application | 2011-02-17 | Corifact | CBER |
2 | 125398 | Coagulation Factor XIII A Subunit (Recombinant) Application | 2013-12-23 | TRETTEN | CBER |
# | id | title | category | type | labeler | labeler act | last update | version | product(s) |
---|
1 | 8664978e-1814-4930-aca5-97a24455f6df (view SPL) | These highlights do not include all the information needed to use TRETTEN safely and effectively. See full prescribing information for TRETTEN. TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant) For Intravenous Use. Lyophilized Powder for Solution for InjectionInitial U.S. Approval: 2013 | other | Plasma Derivative | Novo Nordisk | MANUFACTURE | 2014-04-30 | 2 | 001697013 |
2 | 96f1b658-01b0-43a7-9aba-693271389a78 (view SPL) | These highlights do not include all the information needed to use CORIFACT safely and effectively. See full prescribing information for CORIFACT. Corifact, Factor XIII Concentrate (Human) Lyophilized powder for solution for injection For intravenous use only. Initial U.S. Approval: 2011 | other | Plasma Derivative | Csl Behring Gmbh | MANUFACTURE | 2015-09-30 | 7 | 638330518 |