APPLICATION
NDA017339
TYPE
NDA
ORIGINAL APPROVAL
1974-06-03
LATEST ACTION
2009-03-13
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
MINITECDiscontinued
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.22-2.22 CI/GENERATOR · SOLUTION · INJECTION, ORAL
Approval history
2009-03-13Labeling · Supplement 26AP
2009-03-13Labeling · Supplement 14AP
2009-03-13Labeling · Supplement 20AP
1985-09-30Manufacturing (CMC) · Supplement 29 · standardAP
1985-05-30Manufacturing (CMC) · Supplement 28 · standardAP
1983-05-27Efficacy · Supplement 18AP
1981-11-18Manufacturing (CMC) · Supplement 21 · standardAP
1981-10-22Manufacturing (CMC) · Supplement 22 · standardAP
1981-05-05Manufacturing (CMC) · Supplement 24 · standardAP
1980-02-08Labeling · Supplement 23AP
1979-10-11Manufacturing (CMC) · Supplement 19 · standardAP
1979-05-18Manufacturing (CMC) · Supplement 15 · standardAP
1979-04-05Labeling · Supplement 17AP
1978-03-20Labeling · Supplement 13AP
1977-06-15Manufacturing (CMC) · Supplement 11 · standardAP
1977-02-11Manufacturing (CMC) · Supplement 12 · standardAP
1976-10-21Labeling · Supplement 10AP
1976-02-05Labeling · Supplement 9AP
1975-12-22Manufacturing (CMC) · Supplement 8 · standardAP
1975-09-02Labeling · Supplement 7AP
1974-06-03Type 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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