SUFLAVE (NDA215344)- (0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT)

Generic Name	MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE	Innovator	BRAINTREE LABS
Dosage	0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2026-Jun-15
GAIN Expiry	None	Drug Complexity	No
Indication	SUFLAVE is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

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
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SUFLAVE