APPLICATION
NDA016923
TYPE
NDA
ORIGINAL APPROVAL
1974-06-10
LATEST ACTION
2009-03-13
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
TESULOIDDiscontinued
TECHNETIUM TC-99M SULFUR COLLOID KIT N/A · SOLUTION · INJECTION, ORAL
Approval history
2009-03-13Labeling · Supplement 14AP
2009-03-13Labeling · Supplement 19AP
2009-03-13Labeling · Supplement 8AP
1991-01-25Efficacy · Supplement 20AP
1988-05-18Manufacturing (CMC) · Supplement 18 · standardAP
1985-11-23Efficacy · Supplement 17AP
1985-09-30Manufacturing (CMC) · Supplement 16 · standardAP
1983-08-19Manufacturing (CMC) · Supplement 15 · standardAP
1983-08-02Manufacturing (CMC) · Supplement 11 · standardAP
1982-06-10Labeling · Supplement 12AP
1981-07-20Manufacturing (CMC) · Supplement 13 · standardAP
1980-09-25Labeling · Supplement 10AP
1979-04-30Labeling · Supplement 9AP
1978-03-20Labeling · Supplement 7AP
1977-01-31Labeling · Supplement 5AP
1977-01-31Labeling · Supplement 6AP
1976-07-15Manufacturing (CMC) · Supplement 4 · standardAP
1976-05-10Labeling · Supplement 2AP
1975-08-22Labeling · Supplement 1AP
1974-06-10Type 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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