APPLICATION
NDA018664
TYPE
NDA
ORIGINAL APPROVAL
1982-10-14
LATEST ACTION
2016-12-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IOSAT · ReferenceOver-the-counter
POTASSIUM IODIDE 65MG · TABLET · ORAL
IOSAT · ReferenceOver-the-counter
POTASSIUM IODIDE 130MG · TABLET · ORAL
Approval history
2016-12-20Manufacturing (CMC) · Supplement 18 · standardAP
2016-06-06Manufacturing (CMC) · Supplement 17AP
2015-06-17Manufacturing (CMC) · Supplement 16AP
2015-03-03Manufacturing (CMC) · Supplement 15AP
2011-05-12Manufacturing (CMC) · Supplement 13AP
2005-01-14Labeling · Supplement 7AP
2000-09-13Manufacturing (CMC) · Supplement 2AP
1985-11-04Manufacturing (CMC) · Supplement 1AP
1982-10-14OriginalAP
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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