OSMOPREP (nda021892)- (0.398GM;1.102GM)

Generic Name	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	Innovator	SALIX PHARMS
Dosage	0.398GM;1.102GM
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2028-Jun-22	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OsmoPrep 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
1	0	1

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
0.398GM;1.102GM	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OSMOPREP