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Setid 524a0dac 6e2b 2c0c 04b4 76d85dba63c5 Applno 21305 Form Solution Oral Dosage 250 1000mci - Drug Product Composition: Sodium iodide (I-131)

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USFDA APPLICATION NUMBER - 21305 / DOSAGE - SOLUTION;ORAL - 250-1000mCi

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-1311000mCi in 1

Inactive Ingredients

Ingredient Name
International Isotopes Inc
Jubilant DraxImage Inc., dba Jubilant Radiopharma
EDETATE DISODIUM(7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(94255I6E2T) 
Sodium Thiosulfate(HX1032V43M)