APPLICATION
NDA018671
TYPE
NDA
ORIGINAL APPROVAL
1982-05-27
LATEST ACTION
2008-06-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued
Products
SODIUM IODIDE I 123 · ReferencePrescription
SODIUM IODIDE I-123 200uCi · CAPSULE · ORAL
SODIUM IODIDE I 123Discontinued
SODIUM IODIDE I-123 400uCi · CAPSULE · ORAL
SODIUM IODIDE I 123 · ReferencePrescription
SODIUM IODIDE I-123 100uCi · CAPSULE · ORAL
Approval history
2000-10-19Labeling · Supplement 10 · standardAP
1998-02-02Labeling · Supplement 9 · standardAP
1998-01-23Labeling · Supplement 8 · standardAP
1997-11-04Manufacturing (CMC) · Supplement 7 · standardAP
1996-10-28Manufacturing (CMC) · Supplement 6 · standardAP
1994-03-17Labeling · Supplement 5AP
1988-07-12Labeling · Supplement 4AP
1985-12-31Manufacturing (CMC) · Supplement 3 · standardAP
1985-09-09Labeling · Supplement 1AP
1985-07-12Manufacturing (CMC) · Supplement 2 · standardAP
1982-05-27Type 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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