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Generated: February 15, 2019

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Details for New Drug Application (NDA): 071909

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NDA 071909 describes SODIUM IODIDE I 123, which is a drug marketed by Cardinal Health 418, Ge Healthcare, and Mallinkrodt Nuclear, and is included in four NDAs. It is available from two suppliers. Additional details are available on the SODIUM IODIDE I 123 profile page.

The generic ingredient in SODIUM IODIDE I 123 is sodium iodide i-123. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-123 profile page.
Summary for 071909
Tradename:SODIUM IODIDE I 123
Applicant:Mallinkrodt Nuclear
Ingredient:sodium iodide i-123
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 071909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 071909 ANDA Curium US LLC 69945-601 69945-601-10 1 BOTTLE in 1 CAN (69945-601-10) > 1 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100uCi
Approval Date:Feb 28, 1989TE:AARLD:No

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