TIS-U-SOL IN PLASTIC CONTAINER (nda018336)- (20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML)

Generic Name	MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE	Innovator	BAXTER HLTHCARE
Dosage	20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
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	TI-U-SOL IN PLASTIC CONTAINER Isotonic solution for irrigation only. Not for injection.

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
20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TIS-U-SOL IN PLASTIC CONTAINER