Setid 65ab2356 9f16 52b9 E053 2a91aa0abd05 Applno 202158 Form Solution Intravenous Intravesicular Ophthalmic Dosage 30 1153mci Generator - Drug Product Composition: Pertechnetate Sodium

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38 FDF Dossiers, 13 FDA Orange Book, 4 Europe, 1 Canada, 20 South Africa

SOLUTION;INTRAVENOUS - 1-19 CI/GENERATOR, SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC - 30-1153mCi/GENERATOR

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USFDA APPLICATION NUMBER - 202158 / DOSAGE - SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC - 30-1153mCi/GENERATOR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TECHNETIUM TC-99M SODIUM PERTECHNETATE(UNII: A0730CX801) (TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1)	TECHNETIUM TC-99M PERTECHNETATE	7.5Ci in 7.5 \| 19Ci in 19 \| 15Ci in 15 \| 12Ci in 12

Pertechnetate Sodium