← FDA DRUG APPROVALS

FDA NDA · NDA020912

AGGRASTAT

tirofiban

Sponsor: MEDICURE

APPLICATION
NDA020912
TYPE
NDA
ORIGINAL APPROVAL
1998-05-14
LATEST ACTION
2019-05-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
SOLUTION, INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

AGGRASTAT · ReferencePrescription
TIROFIBAN HYDROCHLORIDE EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) · SOLUTION · INJECTION
AGGRASTATDiscontinued
TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2019-05-16Labeling · Supplement 27 · standard — Letter ↗AP
2016-08-31Manufacturing (CMC) · Supplement 24 · unknown — Label ↗AP
2015-04-21Labeling · Supplement 21 · standard — Letter ↗AP
2013-10-10Labeling · Supplement 20 · standard — Letter ↗AP
2013-10-10Efficacy · Supplement 19 · standard — Label ↗AP
2012-06-06Labeling · Supplement 18 · unknown — Label ↗AP
2003-02-28Labeling · Supplement 13 · standard — Letter ↗AP
2002-07-24Labeling · Supplement 9 · standard — Letter ↗AP
2002-06-17Labeling · Supplement 12 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 11 · priorityAP
2002-01-17Manufacturing (CMC) · Supplement 10 · priorityAP
2001-09-25Labeling · Supplement 8 · standard — Letter ↗AP
2001-03-23Labeling · Supplement 7 · standard — Letter ↗AP
2001-02-08Manufacturing (CMC) · Supplement 6 · priorityAP
2000-12-15Manufacturing (CMC) · Supplement 5 · priorityAP
2000-01-11Labeling · Supplement 4 · standard — Review ↗AP
1999-07-09Labeling · Supplement 1 · standard — Letter ↗AP
1999-06-09Labeling · Supplement 2 · standardAP
1998-05-14Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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