NILANDRON (nda020169)- (50MG,150MG)

Generic Name	NILUTAMIDE	Innovator	CONCORDIA
Dosage	50MG,150MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
50MG	**	**	-	-	-
150MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of NILANDRON