APPLICATION
NDA017471
TYPE
NDA
ORIGINAL APPROVAL
1974-07-18
LATEST ACTION
1983-02-02
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SODIUM PERTECHNETATE TC 99M · ReferenceDiscontinued
TECHNETIUM TC-99M SODIUM PERTECHNETATE 2-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INJECTION, ORAL
Approval history
1983-02-02Efficacy · Supplement 8 · standardAP
1979-07-20Manufacturing (CMC) · Supplement 9 · standardAP
1979-01-22Labeling · Supplement 10 · standardAP
1978-02-21Manufacturing (CMC) · Supplement 7 · standardAP
1977-01-24Manufacturing (CMC) · Supplement 6 · standardAP
1977-01-17Labeling · Supplement 5 · standardAP
1974-07-18Type 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.
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