Details for New Drug Application (NDA): 020913
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NDA 020913 describes AGGRASTAT, which is a drug marketed by Medicure and is included in two NDAs. It is available from one supplier. Additional details are available on the AGGRASTAT profile page.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 020913
| Tradename: | AGGRASTAT |
| Applicant: | Medicure |
| Ingredient: | tirofiban hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020913
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 020913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-01 | 1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG |
| AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-02 | 1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | May 14, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | May 17, 2002 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Apr 20, 2000 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 020913
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-001 | May 14, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913-003 | Apr 20, 2000 | ⤷ Subscribe | ⤷ Subscribe |
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