HICON (nda021305)- (1-250mCi/0.25ML,1-500mCi/0.5ML,1-1000mCi/ML,250-1000mCi)

Generic Name	SODIUM IODIDE I-131	Innovator	JUBILANT
Dosage	1-250mCi/0.25ML,1-500mCi/0.5ML,1-1000mCi/ML,250-1000mCi
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	HICON® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	14

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1-250mCi/0.25ML	**	**	-	-	-
1-500mCi/0.5ML	**	**	-	-	-
1-1000mCi/ML	**	**	-	-	-
250-1000mCi	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of HICON