PROTOPAM CHLORIDE (nda014122)- (500MG)

Generic Name	PRALIDOXIME CHLORIDE	Innovator	WYETH AYERST
Dosage	500MG
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	PROTOPAM is indicated as an antidote: (1) In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and (2) In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.

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
500MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PROTOPAM CHLORIDE