← FDA DRUG APPROVALS

FDA NDA · NDA021305

HICON

sodium iodide i 131

Sponsor: JUBILANT

APPLICATION
NDA021305
TYPE
NDA
ORIGINAL APPROVAL
2003-01-24
LATEST ACTION
2021-06-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION, CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

HICON · ReferencePrescription
SODIUM IODIDE I-131 250-1000mCi · SOLUTION · ORAL
HICONDiscontinued
SODIUM IODIDE I-131 1-1000mCi/ML · SOLUTION · ORAL
HICONDiscontinued
SODIUM IODIDE I-131 1-500mCi/0.5ML · SOLUTION · ORAL
SODIUM IODIDE I 131 · ReferencePrescription
SODIUM IODIDE I-131 0.009-0.1mCi · CAPSULE · ORAL
SODIUM IODIDE I 131Discontinued
SODIUM IODIDE I-131 2-200mCi · CAPSULE · ORAL
HICONDiscontinued
SODIUM IODIDE I-131 1-250mCi/0.25ML · SOLUTION · ORAL

Approval history

2021-06-11Labeling · Supplement 47 · standard — Label ↗AP
2016-07-08Labeling · Supplement 42 · standard — Letter ↗AP
2016-06-15Labeling · Supplement 41 · standard — Letter ↗AP
2016-04-01Manufacturing (CMC) · Supplement 39 · standardAP
2015-07-31Manufacturing (CMC) · Supplement 40 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 38 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 35 · standardAP
2012-12-07Manufacturing (CMC) · Supplement 34 · standardAP
2012-12-07Manufacturing (CMC) · Supplement 33 · standardAP
2011-10-03Manufacturing (CMC) · Supplement 27 · standard — Letter ↗AP
2011-09-23Labeling · Supplement 25 · standard — Letter ↗AP
2008-02-29Labeling · Supplement 16 · standard — Label ↗AP
2008-01-17Manufacturing (CMC) · Supplement 15AP
2007-04-18Labeling · Supplement 11 · standard — Label ↗AP
2006-10-23Labeling · Supplement 10 · standard — Letter ↗AP
2006-04-04Manufacturing (CMC) · Supplement 8AP
2006-01-06Labeling · Supplement 5 · standard — Label ↗AP
2005-05-19Efficacy · Supplement 3 · unknown — Letter ↗AP
2004-11-18Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2003-08-08Labeling · Supplement 1 · standard — Letter ↗AP
2003-01-24Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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