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Generated: January 23, 2019

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Details for New Drug Application (NDA): 021305

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NDA 021305 describes HICON, which is a drug marketed by Jubilant Draximage and is included in one NDA. It is available from one supplier. Additional details are available on the HICON profile page.

The generic ingredient in HICON 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 021305
Tradename:HICON
Applicant:Jubilant Draximage
Ingredient:sodium iodide i-131
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021305
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 021305
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM IODIDE I 131 sodium iodide i-131 CAPSULE;ORAL 021305 NDA Jubilant DraxImage Inc. 65174-461 65174-461-05 5 CAPSULE in 1 VIAL (65174-461-05)
HICON sodium iodide i-131 SOLUTION;ORAL 021305 NDA Jubilant DraxImage Inc. 65174-461 65174-461-05 5 CAPSULE in 1 VIAL (65174-461-05)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1-250mCi/0.25ML
Approval Date:Jan 24, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1-500mCi/0.5ML
Approval Date:Jan 24, 2003TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength2-200mCi
Approval Date:Nov 18, 2004TE:RLD:No

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