Reteplase Injectable Solution
- Brand(s)
- Retavase
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Ekr Therapeutics, Inc. (2010-01-05)
- Oldest Current Product
- 1996-10-30
- License(s)
- BLA
- RxNORM
- INJECTABLE SOLUTION\RETEPLASE
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RETEPLASE
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RETEPLASE
product(s) by strength(s)
reteplase 1 unt/ml injectable solution
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|
1 | 244770040 | Retavase | BLA | Ekr Therapeutics, Inc. | 1996-10-30 | RETEPLASE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 103786 | e9ae6656-977c-4105-8528-bee664aab27a |
# | id | title | approved | tradenames | fda division |
---|
1 | 103786 | reteplase Application | 1996-10-30 | Retavase | CDER |
# | id | title | category | type | labeler | labeler act | last update | version | product(s) |
---|
1 | e9ae6656-977c-4105-8528-bee664aab27a (view SPL) | Retavase Reteplase, recombinant | prescription | Human Prescription | Ekr Therapeutics, Inc. | MANUFACTURE | 2010-01-05 | 3 | 244770040, 244770041 |