CYSTAGON (nda020392)- (EQ 50MG BASE,EQ 150MG BASE)

Generic Name	CYSTEAMINE BITARTRATE	Innovator	MYLAN
Dosage	EQ 50MG BASE,EQ 150MG BASE
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	CYSTAGON® is indicated for the management of nephropathic cystinosis in children and adults.

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
EQ 50MG BASE	**	**	-	-	-
EQ 150MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CYSTAGON