TECHNELITE (nda017771)- (0.0083-2.7 CI/GENERATOR,1-20 CI/GENERATOR)

Generic Name	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	Innovator	LANTHEUS MEDCL
Dosage	0.0083-2.7 CI/GENERATOR,1-20 CI/GENERATOR
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. *Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: -Thyroid Imaging -Salivary Gland Imaging -Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. -Nasolacrimal Drainage System Imaging (dacryoscintigraphy) Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: -Thyroid Imaging -Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.0083-2.7 CI/GENERATOR	**	**	-	-	-
1-20 CI/GENERATOR	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TECHNELITE