COLYTE-FLAVORED (nda018983)- (227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT,240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT)

Generic Name	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	Innovator	NORVIUM BIOSCIENCE
Dosage	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT,240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
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	Colyte® with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

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
227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT	**	**	-	-	-
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of COLYTE-FLAVORED