MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE (nda022456)- (343MG;20MG;750MG,343MG;40MG;750MG)

Generic Name	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	Innovator	SANTARUS
Dosage	343MG;20MG;750MG,343MG;40MG;750MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2016-Jul-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets is a proton pump inhibitor indicated for: • Treatment of duodenal ulcer • Treatment of gastric ulcer • Treatment of gastroesophageal reflux disease (GERD) • Maintenance of healing of erosive esophagitis

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
343MG;20MG;750MG	**	**	-	-	-
343MG;40MG;750MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE