APPLICATION
NDA017907
TYPE
NDA
ORIGINAL APPROVAL
1978-05-25
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GLUCOSCANDiscontinued
TECHNETIUM TC-99M GLUCEPTATE KIT N/A · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 5AP
2007-12-07Labeling · Supplement 1AP
1990-03-26Manufacturing (CMC) · Supplement 11 · standardAP
1989-05-02Manufacturing (CMC) · Supplement 10 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 8 · standardAP
1978-05-25Type 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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