MAGNESIUM SULFATE IN PLASTIC CONTAINER (nda020309)- (2GM/50ML (40MG/ML),4GM/100ML (40MG/ML),4GM/50ML (80MG/ML),20GM/500ML (40MG/ML),40GM/1000ML (40MG/ML))

Generic Name	MAGNESIUM SULFATE	Innovator	HOSPIRA
Dosage	2GM/50ML (40MG/ML),4GM/100ML (40MG/ML),4GM/50ML (80MG/ML),20GM/500ML (40MG/ML),40GM/1000ML (40MG/ML)
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	Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

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
2GM/50ML (40MG/ML)	**	**	-	-	-
4GM/100ML (40MG/ML)	**	**	-	-	-
4GM/50ML (80MG/ML)	**	**	-	-	-
20GM/500ML (40MG/ML)	**	**	-	-	-
40GM/1000ML (40MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of MAGNESIUM SULFATE IN PLASTIC CONTAINER