Antithrombin III Injection
- Brand(s)
- ATryn, Thrombate III
- Category(s)
- other, prescription
- SPL Type(s)
- Human Prescription, Human Prescription with Highlights, Plasma Derivative
- Master SPL
- Grifols (2013-08-31)
- Oldest Current Product
- 1991-12-30
- License(s)
- BLA
- RxNORM
- INJECTION\ANTITHROMBIN III
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTITHROMBIN ALFA
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTITHROMBIN ALFA
product(s) by strength(s)
antithrombin iii, human 1 unt injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 135330604 | Thrombate III | BLA | Grifols | 1991-12-30 | 103196 | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 |
antithrombin alfa 1 unt injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 429760121 | ATryn | BLA | Gtc Biotherapeutics, Inc. | 2009-05-06 | ANTITHROMBIN ALFA | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 125284 | ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1 |
| 2 | 673860521 | ATryn | BLA | Lundbeck Inc. | 2009-02-06 | ANTITHROMBIN ALFA | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 125284 | e17ed76e-bc13-4ba2-bf1c-886fe748df4c |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 103196 | Antithrombin III (Human) Application | 1991-12-30 | Thrombate III | CBER |
| 2 | 125284 | Antithrombin (Recombinant) Application | 2009-02-06 | ATryn | CBER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 (view SPL) | Antithrombin III (Human) THROMBATE III | other | Plasma Derivative | Grifols | MANUFACTURE | 2013-08-31 | 11 | 135330604, 135330603 |
| 2 | e17ed76e-bc13-4ba2-bf1c-886fe748df4c (view SPL) | These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009 | prescription | Human Prescription with Highlights | Lundbeck Inc. | ANALYSIS, MANUFACTURE | 2010-06-04 | 1 | 673860521 |
| 3 | ecc5f10c-e89e-4757-a56a-9cfa6fd383f7 (view SPL) | These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009 | prescription | Human Prescription | Gtc Biotherapeutics, Inc. | 2013-12-01 | 1 | 429760125 | |
| 4 | ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1 (view SPL) | These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009 | prescription | Human Prescription | Gtc Biotherapeutics, Inc. | manufacture | 2010-11-15 | 1 | 429760121 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII