ACTIVE SUBSTANCE / INN

AZILSARTAN MEDOXOMIL

Brand name(s): Ipreziv, Edarbi, AZILSARTAN MEDOXOMIL

FDA LISTED

EMA LISTED

WITHDRAWN

AUTHORISED

NONE (TENTATIVE APPROVAL)

Hypertension

ANDA219062

ACTIVE SUBSTANCE

Azilsartan Medoxomil

REGULATORS

FDA · EMA

SPONSORS / MAH

HETERO LABS LIMITED, Takeda Pharma A/S

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
AZILSARTAN MEDOXOMIL	ANDA219062	HETERO LABS LIMITED	None (Tentative Approval)

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Edarbi	Takeda Pharma A/S	Authorised	07/12/2011	Hypertension
Ipreziv	Takeda Pharma A/S	Withdrawn	07/12/2011	Hypertension

FULL INTELLIGENCE ON AZILSARTAN MEDOXOMIL