APPLICATION
NDA019882
TYPE
NDA
ORIGINAL APPROVAL
1990-06-15
LATEST ACTION
2014-07-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TECHNESCAN MAG3 · ReferencePrescription
TECHNETIUM TC-99M MERTIATIDE KIT N/A · INJECTABLE · INJECTION
Approval history
2014-07-28Manufacturing (CMC) · Supplement 10 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 7 · standardAP
1998-04-08Manufacturing (CMC) · Supplement 6 · standardAP
1994-03-11Manufacturing (CMC) · Supplement 5 · standardAP
1994-03-11Manufacturing (CMC) · Supplement 4 · standardAP
1993-02-26Labeling · Supplement 2AP
1992-11-27Labeling · Supplement 3AP
1992-11-27Efficacy · Supplement 1AP
1990-06-15Type 1 - New Molecular Entity · Original · standardAP
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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