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Generated: January 20, 2019

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Details for New Drug Application (NDA): 016517

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NDA 016517 describes SODIUM IODIDE I 131, which is a drug marketed by CIS, Jubilant Draximage, and Mallinkrodt Nuclear, and is included in five NDAs. It is available from one supplier. 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 four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium iodide i-131 profile page.
Summary for 016517
Tradename:SODIUM IODIDE I 131
Applicant:Mallinkrodt Nuclear
Ingredient:sodium iodide i-131
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.8-100mCi
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15-100uCi
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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