MOVIPREP (nda021881)- (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)

Generic Name	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	Innovator	SALIX PHARMS
Dosage	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Sep-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MoviPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	1

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	**	**	Down	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of MOVIPREP