VIADUR (nda021088)- (EQ 65MG BASE)

Generic Name	LEUPROLIDE ACETATE	Innovator	ORTHO MCNEIL JANSSEN
Dosage	EQ 65MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2018-Dec-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Viadur® is indicated in the palliative treatment of advanced prostate cancer.

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 65MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of VIADUR