Details for New Drug Application (NDA): 021305

NDA 021305 describes HICON, which is a drug marketed by Jubilant 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. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-131 profile page.

Summary for 021305

Tradename:	HICON
Applicant:	Jubilant
Ingredient:	sodium iodide i-131
Patents:	0

Pharmacology for NDA: 021305

Mechanism of Action

Radiopharmaceutical 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., dba Jubilant Radiopharma	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., dba Jubilant Radiopharma	65174-461	65174-461-05	5 CAPSULE in 1 VIAL (65174-461-05)

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1-250mCi/0.25ML
Approval Date:	Jan 24, 2003	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1-500mCi/0.5ML
Approval Date:	Jan 24, 2003	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2-200mCi
Approval Date:	Nov 18, 2004	TE:		RLD:	No

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