PRAVIGARD PAC (COPACKAGED) (nda021387)- (81MG;20MG,81MG;40MG,81MG;80MG,325MG;20MG,325MG;40MG,325MG;80MG)

Generic Name	ASPIRIN; PRAVASTATIN SODIUM	Innovator	BRISTOL MYERS SQUIBB
Dosage	81MG;20MG,81MG;40MG,81MG;80MG,325MG;20MG,325MG;40MG,325MG;80MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2208-Jul-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PRAVIGARD (Buffered Aspirin and Pravastatin Sodium) is indicated in patients for whom treatment with both PRAVACHOL and buffered aspirin is appropriate. PRAVIGARD are both indicated to reduce the occurrence of cardiovascular events, including death, myocardial infarction or stroke in patients who have clinical evidence of cardiovascular and/or cerebrovascular disease.

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
81MG;20MG	**	**	-	-	-
81MG;40MG	**	**	-	-	-
81MG;80MG	**	**	-	-	-
325MG;20MG	**	**	-	-	-
325MG;40MG	**	**	-	-	-
325MG;80MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PRAVIGARD PAC (COPACKAGED)