RAZADYNE ER (nda021615)- (EQ 8MG BASE,EQ 16MG BASE,EQ 24MG BASE)

Generic Name	GALANTAMINE HYDROBROMIDE	Innovator	JANSSEN PHARMS
Dosage	EQ 8MG BASE,EQ 16MG BASE,EQ 24MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Dec-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RAZADYNE ® ER is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	2

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
EQ 8MG BASE	**	**	Up	2	-
EQ 16MG BASE	**	**	Down	-	2
EQ 24MG BASE	**	**	Up	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of RAZADYNE ER