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FDA NDA · NDA020491

CORVERT

ibutilide fumarate

Sponsor: PFIZER

APPLICATION
NDA020491
TYPE
NDA
ORIGINAL APPROVAL
1995-12-28
LATEST ACTION
2014-06-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CORVERT · ReferencePrescription
IBUTILIDE FUMARATE 0.1MG/ML · INJECTABLE · INJECTION

Approval history

2014-06-09Manufacturing (CMC) · Supplement 9 · standardAP
2002-10-17Manufacturing (CMC) · Supplement 5 · standardAP
2001-04-20Labeling · Supplement 3 · standard — Label ↗AP
2000-04-03Manufacturing (CMC) · Supplement 4 · standardAP
1999-05-13Efficacy · Supplement 1 · standard — Review ↗AP
1998-04-03Labeling · Supplement 2 · standard — Review ↗AP
1995-12-28Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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