Application 020913
- Type
- NDA
- Sponsor
- MEDICURE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | Yes | No |
| 003 | AGGRASTAT | TIROFIBAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25208-002 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-002 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-002 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
| 25208-002 | AGGRASTAT | TIROFIBAN | Medicure International Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67915 | SUPPL | 2021-06-28 |
| 67880 | SUPPL | 2021-06-24 |
| 58794 | SUPPL | 2019-05-20 |
| 58769 | SUPPL | 2019-05-17 |
| 45213 | SUPPL | 2016-09-07 |
| 35637 | SUPPL | 2015-04-28 |
| 3739 | SUPPL | 2015-04-22 |
| 13731 | SUPPL | 2012-06-11 |
| 26186 | SUPPL | 2012-06-08 |
| 41807 | ORIG | 2010-06-04 |
| 41808 | SUPPL | 2004-05-26 |
| 21275 | SUPPL | 2004-05-26 |
| 3738 | SUPPL | 2003-07-24 |
| 26184 | SUPPL | 2002-07-24 |
| 26185 | SUPPL | 2002-05-17 |
| 3737 | SUPPL | 2001-09-25 |
| 3736 | SUPPL | 2001-03-23 |
| 35636 | SUPPL | 1999-07-09 |
| 26183 | SUPPL | 1999-07-09 |
| 35635 | ORIG | 1998-05-14 |
| 3735 | ORIG | 1998-05-14 |