SODIUM BICARBONATE IN PLASTIC CONTAINER (nda019443)- (0.9MEQ/ML,1MEQ/ML)

Generic Name	SODIUM BICARBONATE	Innovator	ABBOTT
Dosage	0.9MEQ/ML,1MEQ/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	Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.9MEQ/ML	**	**	-	-	-
1MEQ/ML	**	**	-	2	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of SODIUM BICARBONATE IN PLASTIC CONTAINER