Application 020912
- Type
- NDA
- Sponsor
- MEDICURE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | No | No |
| 002 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | SOLUTION;INJECTION | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020912-001 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | ||
| N020912-002 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020912-001 | AGGRASTAT | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE / INJECTION | 1998-05-14 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020912-002 | AGGRASTAT | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION / INJECTION | RLD, RS | 2016-08-31 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020912-001 | 6136794 | 2019-01-29 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020912-002 | 6136794 | 2019-01-29 | U-1898 | 2016-09-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020912-001 | 6136794 | 2019-01-29 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020912-002 | 6136794 | 2019-01-29 | U-1898 | 2016-09-29 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020912-001 | 6136794 | 2019-01-29 | b00525d2431f… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020912-002 | 6136794 | 2019-01-29 | U-1898 | 2016-09-29 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020912-001 | 6136794 | 2019-01-29 | ea99ee380514… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020912-002 | 6136794 | 2019-01-29 | U-1898 | 2016-09-29 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | ea99ee380514… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020912-001 | 6770660 | 2023-05-01 | U-1444 | 2013-11-07 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020912-002 | 6770660 | 2023-05-01 | U-1444 | 2016-09-29 | 9b2671bbb829… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AGGRASTAT | TIROFIBAN | Medicure International Inc | fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f | 2025-01-01 | Warnings, Adverse reactions | 020912 NDA020912 25208-001 |
| AGGRASTAT | TIROFIBAN | Medicure International Inc | e850111f-e713-41a2-9c65-21c517cf5511 | 2025-01-01 | Warnings, Adverse reactions | 020912 NDA020912 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25208-001 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-001 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-001 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-001 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58793 | SUPPL | 2019-05-20 |
| 58768 | SUPPL | 2019-05-17 |
| 45214 | SUPPL | 2016-08-31 |
| 35634 | SUPPL | 2015-04-28 |
| 3734 | SUPPL | 2015-04-22 |
| 35633 | SUPPL | 2013-10-17 |
| 13730 | SUPPL | 2013-10-17 |
| 26182 | SUPPL | 2013-10-11 |
| 3733 | SUPPL | 2013-10-11 |
| 13729 | SUPPL | 2012-06-11 |
| 26181 | SUPPL | 2012-06-08 |
| 26180 | SUPPL | 2004-05-26 |
| 21274 | SUPPL | 2004-05-26 |
| 21273 | SUPPL | 2004-05-26 |
| 3732 | SUPPL | 2003-03-10 |
| 26179 | SUPPL | 2002-07-24 |
| 3731 | SUPPL | 2001-09-25 |
| 26178 | SUPPL | 2001-03-23 |
| 35632 | SUPPL | 1999-07-09 |
| 3730 | SUPPL | 1999-07-09 |
| 13728 | ORIG | 1998-05-14 |
| 3729 | ORIG | 1998-05-14 |