← FDA DRUG APPROVALS

FDA NDA · NDA019829

CERETEC

technetium tc-99m exametazime

Sponsor: GE HEALTHCARE

APPLICATION
NDA019829
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2018-09-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CERETEC · ReferencePrescription
TECHNETIUM TC-99M EXAMETAZIME KIT N/A · INJECTABLE · INJECTION

Approval history

2018-09-19Labeling · Supplement 34 · standard — Label ↗AP
2016-04-08Manufacturing (CMC) · Supplement 28 · priorityAP
2014-06-27Manufacturing (CMC) · Supplement 27 · priorityAP
2013-08-05Labeling · Supplement 26 · standard — Letter ↗AP
2013-03-08Manufacturing (CMC) · Supplement 25 · priorityAP
2005-06-15Labeling · Supplement 19 · standard — Letter ↗AP
2002-11-25Manufacturing (CMC) · Supplement 14 · priorityAP
2001-08-17Manufacturing (CMC) · Supplement 13 · priorityAP
2001-04-10Manufacturing (CMC) · Supplement 12 · priorityAP
2000-09-29Manufacturing (CMC) · Supplement 11 · priorityAP
1999-11-12Manufacturing (CMC) · Supplement 10 · priorityAP
1996-11-27Manufacturing (CMC) · Supplement 9 · priorityAP
1995-04-07Manufacturing (CMC) · Supplement 6 · priorityAP
1995-04-07Manufacturing (CMC) · Supplement 4 · priorityAP
1995-04-07Efficacy · Supplement 5AP
1994-07-25Manufacturing (CMC) · Supplement 8 · priorityAP
1993-03-02Manufacturing (CMC) · Supplement 1 · priorityAP
1988-12-30Type 1 - New Molecular Entity · Original · priorityAP
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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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