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Details for New Drug Application (NDA): 016515

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NDA 016515 describes SODIUM IODIDE I 131, which is a drug marketed by Jubilant Draximage, Mallinkrodt Nuclear, and CIS, and is included in five NDAs. It is available from three suppliers. Additional details are available on the SODIUM IODIDE I 131 profile page.

The generic ingredient in SODIUM IODIDE I 131 is sodium iodide i-131. There are one thousand three hundred and twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium iodide i-131 profile page.

Summary for NDA: 016515

Mallinkrodt Nuclear
sodium iodide i-131

Pharmacology for NDA: 016515

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 016515

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium iodide i-131
CAPSULE;ORAL 016515 NDA Mallinckrodt Inc. 0019-9450 0019-9450-01 1 VIAL in 1 CAN (0019-9450-01) > 1 mL in 1 VIAL
sodium iodide i-131
CAPSULE;ORAL 016515 NDA Mallinckrodt Inc. 0019-9450 0019-9450-02 1 VIAL in 1 CAN (0019-9450-02) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength3.5-150mCi/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.8-100mCi
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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