APPLICATION
NDA017725
TYPE
NDA
ORIGINAL APPROVAL
1977-12-30
LATEST ACTION
1989-04-19
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SODIUM PERTECHNETATE TC 99M · ReferenceDiscontinued
TECHNETIUM TC-99M SODIUM PERTECHNETATE 10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INJECTION, ORAL
Approval history
1989-04-19Manufacturing (CMC) · Supplement 7 · standardAP
1988-07-20Manufacturing (CMC) · Supplement 8 · standardAP
1988-07-20Manufacturing (CMC) · Supplement 6 · standardAP
1986-09-09Labeling · Supplement 5AP
1986-09-09Efficacy · Supplement 10AP
1983-04-18Manufacturing (CMC) · Supplement 3 · standardAP
1982-10-05Labeling · Supplement 4AP
1979-08-14Labeling · Supplement 2AP
1979-01-10Manufacturing (CMC) · Supplement 1 · standardAP
1977-12-30Type 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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