APPLICATION
NDA017784
TYPE
NDA
ORIGINAL APPROVAL
1976-11-18
LATEST ACTION
1989-02-17
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
TECHNETIUM TC 99M TSCDiscontinued
TECHNETIUM TC-99M SULFUR COLLOID KIT N/A · SOLUTION · INJECTION, ORAL
Approval history
1989-02-17Manufacturing (CMC) · Supplement 18 · standardAP
1988-12-23Manufacturing (CMC) · Supplement 17 · standardAP
1988-12-15Labeling · Supplement 19 · standardAP
1987-07-02Efficacy · Supplement 15 · standardAP
1985-04-19Labeling · Supplement 14 · standardAP
1982-12-07Manufacturing (CMC) · Supplement 12 · standardAP
1982-12-07Labeling · Supplement 13 · standardAP
1982-08-12Labeling · Supplement 10 · standardAP
1981-04-27Labeling · Supplement 11 · standardAP
1979-10-09Labeling · Supplement 6 · standardAP
1978-08-28Labeling · Supplement 7 · standardAP
1977-09-13Labeling · Supplement 3 · standardAP
1977-09-12Labeling · Supplement 4 · standardAP
1977-08-09Manufacturing (CMC) · Supplement 2 · standardAP
1977-08-09Manufacturing (CMC) · Supplement 1 · standardAP
1976-11-18Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.