← FDA DRUG APPROVALS

FDA NDA · NDA019785

CARDIOLITE

tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate

Sponsor: SHINE

APPLICATION
NDA019785
TYPE
NDA
ORIGINAL APPROVAL
1990-12-21
LATEST ACTION
2019-12-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

MIRALUMADiscontinued
TECHNETIUM TC-99M SESTAMIBI KIT N/A · INJECTABLE · INJECTION
CARDIOLITE · ReferencePrescription
TECHNETIUM TC-99M SESTAMIBI KIT N/A · INJECTABLE · INJECTION

Approval history

2019-12-04Labeling · Supplement 22 · standard — Letter ↗AP
2008-04-30Efficacy · Supplement 18 · unknown — Summary Review ↗AP
2002-01-22Labeling · Supplement 12 · standardAP
2000-06-08Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-11Manufacturing (CMC) · Supplement 14 · standardAP
2000-01-14Labeling · Supplement 13 · standardAP
1998-06-10Manufacturing (CMC) · Supplement 11 · standardAP
1997-08-08Manufacturing (CMC) · Supplement 10 · standardAP
1997-05-23Efficacy · Supplement 6 · standardAP
1997-04-24Manufacturing (CMC) · Supplement 9 · standardAP
1996-11-08Manufacturing (CMC) · Supplement 7 · standardAP
1996-09-26Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-28Manufacturing (CMC) · Supplement 3 · standardAP
1995-12-14Efficacy · Supplement 4 · standardAP
1995-12-14Efficacy · Supplement 5 · standardAP
1992-09-09Efficacy · Supplement 2AP
1992-01-30Manufacturing (CMC) · Supplement 1 · standardAP
1990-12-21Type 1 - New Molecular Entity · Original · standardAP
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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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