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Setid Ad7ceaae F753 4ac9 8b12 422c92855c94 Applno 16517 Form Capsule Oral Dosage 0 8 100mci - Drug Product Composition: Sodium Iodide-131

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USFDA APPLICATION NUMBER - 16517 / DOSAGE - CAPSULE;ORAL - 0.8-100mCi

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM IODIDE I-131(UNII: 29VCO8ACHH)
(IODIDE ION I-131 - UNII:4GC1FOQ22U)
IODIDE ION I-1311mCi in 1

Inactive Ingredients

Ingredient Name
Mallinckrodt Inc.
MALLINCKRODT NUCLEAR MEDICINE LLC
EDETATE DISODIUM(7FLD91C86K)
SODIUM BISULFATE(BU8V88OWIQ)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)