EXXUA (NDA021164)- (EQ 18.2MG BASE,EQ 36.3MG BASE,EQ 54.5MG BASE,EQ 72.6MG BASE)

Generic Name	GEPIRONE HYDROCHLORIDE	Innovator	FABRE KRAMER
Dosage	EQ 18.2MG BASE,EQ 36.3MG BASE,EQ 54.5MG BASE,EQ 72.6MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2025-Sep-02	NCE Excl Expiry	2028-Sep-22
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.

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 18.2MG BASE	**	**	-	-	-
EQ 36.3MG BASE	**	**	-	-	-
EQ 54.5MG BASE	**	**	-	-	-
EQ 72.6MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of EXXUA