APPLICATION
NDA018272
TYPE
NDA
ORIGINAL APPROVAL
1982-01-27
LATEST ACTION
2002-05-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TECHNESCAN GLUCEPTATEDiscontinued
TECHNETIUM TC-99M GLUCEPTATE KIT N/A · INJECTABLE · INJECTION
Approval history
2002-05-17Manufacturing (CMC) · Supplement 6 · standardAP
1999-04-02Labeling · Supplement 5 · standardAP
1999-04-02Labeling · Supplement 4 · standardAP
1984-01-27Labeling · Supplement 2AP
1983-01-10Labeling · Supplement 1AP
1982-01-27Type 5 - New Formulation or New Manufacturer · 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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