Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017630

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SODIUM IODIDE I 123 (SODIUM IODIDE I-123)
100uCi
Marketing Status: Discontinued

Active Ingredient: SODIUM IODIDE I-123
Proprietary Name: SODIUM IODIDE I 123
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100uCi
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017630
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

SODIUM IODIDE I 123 (SODIUM IODIDE I-123)
200uCi
Marketing Status: Discontinued

Active Ingredient: SODIUM IODIDE I-123
Proprietary Name: SODIUM IODIDE I 123
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200uCi
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017630
Product Number: 003
Approval Date: Jan 8, 1993
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

SODIUM IODIDE I 123 (SODIUM IODIDE I-123)
2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: SODIUM IODIDE I-123
Proprietary Name: SODIUM IODIDE I 123
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017630
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information