PLENVU (nda209381)- (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)

Generic Name	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	Innovator	SALIX
Dosage	7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2033-Sep-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2021-May-04
GAIN Expiry	None	Drug Complexity	No
Indication	PLENVU 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	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PLENVU