ASPRUZYO SPRINKLE (nda216018)- (1GM,500MG)

Generic Name	RANOLAZINE	Innovator	SPIL
Dosage	1GM,500MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2038-Jan-24	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM	**	**	-	-	-
500MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ASPRUZYO SPRINKLE