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Generated: May 28, 2017

DrugPatentWatch Database Preview

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 three hundred and seventy-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: 021305

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
CAPSULE;ORAL 021305 NDA Jubilant DraxImage Inc. 65174-461 65174-461-05 5 CAPSULE in 1 VIAL (65174-461-05)
sodium iodide i-131
CAPSULE;ORAL 021305 NDA Jubilant DraxImage Inc. 65174-880 65174-880-00 1 VIAL in 1 KIT (65174-880-00) > 1 mL in 1 VIAL

Summary for product number 002

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

Summary for product number 003

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

Summary for product number 004

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

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