Details for New Drug Application (NDA): 020912

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NDA 020912 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 020912

Tradename:	AGGRASTAT
Applicant:	Medicure
Ingredient:	tirofiban hydrochloride
Patents:	0

Pharmacology for NDA: 020912

Physiological Effect	Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 020912

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912	NDA	Medicure International Inc	25208-001	25208-001-04	1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS
AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912	NDA	Medicure International Inc	25208-901	25208-901-04	1 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
Approval Date:	May 14, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
Approval Date:	Aug 31, 2016	TE:		RLD:	Yes

Expired US Patents for NDA 020912

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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