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.

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020913-003	Apr 20, 2000	⤷ 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	020913-001	May 14, 1998	⤷ Sign Up	⤷ Sign Up
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