ULTRA-TECHNEKOW FM (nda017243)- (0.25-3 CI/GENERATOR,1-19 CI/GENERATOR)

Generic Name	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	Innovator	CURIUM
Dosage	0.25-3 CI/GENERATOR,1-19 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 Ultra-TechneKow™ DTE 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 is used IN ADULTS as an agent for: -Thyroid Imaging -Salivary Gland Imaging -Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux -Nasolacrimal Drainage System Imaging (dacryoscintigraphy) *Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for: -Thyroid Imaging -Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteral 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
0.25-3 CI/GENERATOR	**	**	-	-	-
1-19 CI/GENERATOR	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ULTRA-TECHNEKOW FM