SYNAREL (nda019886)- (EQ 0.2MG BASE/SPRAY)

Generic Name	NAFARELIN ACETATE	Innovator	PFIZER
Dosage	EQ 0.2MG BASE/SPRAY
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2011-Jun-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes.

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
EQ 0.2MG BASE/SPRAY	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SYNAREL