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FDA Orange Book · active-ingredient family

Sodium iodide i-123

Sodium iodide i-123 is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SODIUM IODIDE I 123 · NDA 018671

2

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution

ProductApplicantApplicationTEApproved
SODIUM IODIDE I 123RLD×3CARDINAL HEALTH 418NDA 018671AAMay 27, 1982
SODIUM IODIDE I 123×3GE HEALTHCARENDA 017630Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
SODIUM IODIDE I 123CURIUMANDA 071909AAFeb 28, 1989
SODIUM IODIDE I 123CURIUMANDA 071910AAFeb 28, 1989

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Sodium iodide i-123 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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