Details for New Drug Application (NDA): 020913
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Two 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: | 1 |
Formulation / Manufacturing: | see details |
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 | |||||
Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS |
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: | RLD: | Yes | |||||
Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS |
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 | ||||
Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS |
Expired US Patents for NDA 020913
Complete Access Available with Subscription