POTASSIUM CHLORIDE (nda019439)- (10MEQ,20MEQ)

Generic Name	POTASSIUM CHLORIDE	Innovator	SCHERING
Dosage	10MEQ,20MEQ
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2006-Sep-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	POTASSIUM CHLORIDE is indicated for: 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	12

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
10MEQ	**	**	-	1	6
20MEQ	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	9

Manufacturing Details of POTASSIUM CHLORIDE