EDARBI (nda200796)- (EQ 40MG MEDOXOMIL,EQ 80MG MEDOXOMIL)

Generic Name	AZILSARTAN KAMEDOXOMIL	Innovator	AZURITY
Dosage	EQ 40MG MEDOXOMIL,EQ 80MG MEDOXOMIL
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Mar-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	0

Other Developers

Total Other Developers	6

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 40MG MEDOXOMIL	**	**	Up	-	-
EQ 80MG MEDOXOMIL	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of EDARBI