tirofiban Injectable Solution
- Brand(s)
- Aggrastat
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Medicure International Inc (2015-04-30)
- Oldest Current Product
- 1998-05-14
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\TIROFIBAN
- FDAOB
- INJECTION\INJECTION\TIROFIBAN HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\TIROFIBAN HYDROCHLORIDE
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\TIROFIBAN
product(s) by strength(s)
tirofiban 0.05 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 252080002 | Aggrastat | NDA | Medicure International Inc | 1998-05-14 | TIROFIBAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA020913 | fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f |
application(s)
| # | id | title | deprecated | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA020912 | AGGRASTAT | True | MEDICURE INTERNATIONAL INC | 1998-05-14 | p5965581 p6136794 p5972967 p5978698 p5733919 p6770660 | NDA020912_001 |
| 2 | NDA020913 | AGGRASTAT | MEDICURE INTERNATIONAL INC | 1998-05-14 | p5965581 p6136794 p5972967 p5978698 p5733919 p6770660 | NDA020913_001, NDA020913_002, NDA020913_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA020912_001 | discontinued | TIROFIBAN HYDROCHLORIDE (EQ 12.5MG BASE/50ML) | INJECTION | False | 1998-05-14 | AGGRASTAT |
| 2 | NDA020913_001 | discontinued | TIROFIBAN HYDROCHLORIDE (EQ 25MG BASE/500ML) | INJECTION | False | 1998-05-14 | AGGRASTAT |
| 3 | NDA020913_002 | RX | TIROFIBAN HYDROCHLORIDE (EQ 5MG BASE/100ML) | INJECTION | False | 2002-05-17 | AGGRASTAT |
| 4 | NDA020913_003 | RX | TIROFIBAN HYDROCHLORIDE (EQ 12.5MG BASE/250ML) | INJECTION | True | 2000-04-20 | AGGRASTAT |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5733919 (view patent) | 2016-10-23 | NDA020912, NDA020913 |
| 2 | p5965581 (view patent) | 2016-10-23 | NDA020912, NDA020913 |
| 3 | p5972967 (view patent) | 2016-10-23 | NDA020912, NDA020913 |
| 4 | p5978698 (view patent) | 2017-10-08 | NDA020912, NDA020913 |
| 5 | p6136794 (view patent) | 2019-01-29 | NDA020912, NDA020913 |
| 6 | p6770660 (view patent) | 2023-05-01 | NDA020912, NDA020913 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f (view SPL) | These highlights do not include all the information needed to use AGGRASTAT (tirofiban hydrochloride) safely and effectively. See full prescribing information for AGGRASTATAGGRASTAT (tirofiban hydrochloride) injection, for intravenous use Initial U.S. Approval: 1998 | prescription | Human Prescription | Medicure International Inc | analysis, label, manufacture, pack | 2015-04-30 | 8 | 252080002 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII