← FDA DRUG APPROVALS

FDA NDA · NDA020913

AGGRASTAT

tirofiban

Sponsor: MEDICURE

APPLICATION
NDA020913
TYPE
NDA
ORIGINAL APPROVAL
1998-05-14
LATEST ACTION
2020-12-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

AGGRASTAT · ReferencePrescription
TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS
AGGRASTAT · ReferencePrescription
TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS
AGGRASTATDiscontinued
TIROFIBAN HYDROCHLORIDE EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-12-11Manufacturing (CMC) · Supplement 28 · standard — Label ↗AP
2019-05-16Labeling · Supplement 26 · standard — Letter ↗AP
2016-09-07Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 20 · priorityAP
2015-04-21Labeling · Supplement 18 · standard — Letter ↗AP
2013-03-05Manufacturing (CMC) · Supplement 16 · priorityAP
2012-06-06Labeling · Supplement 17 · unknown — Label ↗AP
2002-07-24Labeling · Supplement 8 · standard — Letter ↗AP
2002-06-17Labeling · Supplement 9 · standard — Letter ↗AP
2002-05-17Manufacturing (CMC) · Supplement 10 · priority — Letter ↗AP
2001-09-25Labeling · Supplement 7 · standard — Letter ↗AP
2001-03-23Labeling · Supplement 6 · standard — Letter ↗AP
2000-04-20Manufacturing (CMC) · Supplement 5 · priorityAP
2000-01-11Labeling · Supplement 4 · standard — Review ↗AP
1999-07-09Labeling · Supplement 1 · standard — Review ↗AP
1999-06-09Labeling · Supplement 2 · standardAP
1998-05-14Type 3 - New Dosage Form · Original · priority — Review ↗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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