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Last Updated: June 13, 2024

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. Four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020913
Physiological EffectDecreased 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:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
Approval Date:May 14, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date:May 17, 2002TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date:Apr 20, 2000TE:APRLD: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 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-002 May 17, 2002 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-002 May 17, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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