SUPPRELIN (nda019836)- (EQ 0.2MG BASE/ML,EQ 0.5MG BASE/ML,EQ 1MG BASE/ML)

Generic Name	HISTRELIN ACETATE	Innovator	SHIRE
Dosage	EQ 0.2MG BASE/ML,EQ 0.5MG BASE/ML,EQ 1MG BASE/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2000-Jan-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SUPPRELIN is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP).

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/ML	**	**	-	-	-
EQ 0.5MG BASE/ML	**	**	-	-	-
EQ 1MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SUPPRELIN