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FDA ANDA · ANDA071909

SODIUM IODIDE I 123

Sponsor: CURIUM

APPLICATION
ANDA071909
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-28
LATEST ACTION
1993-06-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SODIUM IODIDE I 123Prescription
SODIUM IODIDE I-123 100uCi · CAPSULE · ORAL

Approval history

1993-06-29Manufacturing (CMC) · Supplement 3AP
1991-03-18Manufacturing (CMC) · Supplement 2AP
1991-03-18Manufacturing (CMC) · Supplement 1AP
1989-02-28OriginalAP
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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