APPLICATION
NDA017630
TYPE
NDA
ORIGINAL APPROVAL
1976-03-24
LATEST ACTION
2005-06-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, SOLUTION
MARKETING STATUS
Discontinued
Products
SODIUM IODIDE I 123Discontinued
SODIUM IODIDE I-123 200uCi · CAPSULE · ORAL
SODIUM IODIDE I 123Discontinued
SODIUM IODIDE I-123 100uCi · CAPSULE · ORAL
SODIUM IODIDE I 123Discontinued
SODIUM IODIDE I-123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
1997-03-10Manufacturing (CMC) · Supplement 10 · priorityAP
1997-02-28Manufacturing (CMC) · Supplement 11 · priorityAP
1993-01-08Manufacturing (CMC) · Supplement 9 · priorityAP
1988-11-18Labeling · Supplement 8AP
1986-07-01Labeling · Supplement 6AP
1982-10-01Manufacturing (CMC) · Supplement 7 · priorityAP
1982-03-22Manufacturing (CMC) · Supplement 4 · priorityAP
1980-05-06Manufacturing (CMC) · Supplement 5 · priorityAP
1979-07-11Manufacturing (CMC) · Supplement 3 · priorityAP
1977-08-03Labeling · Supplement 2AP
1976-03-24Type 1 - New Molecular Entity · Original · priorityAP
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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