ACTIVE SUBSTANCE / INN

GEFITINIB

Brand name(s): Gefitinib Mylan, GEFITINIB, IRESSA, Iressa

FDA LISTED

EMA LISTED

PRESCRIPTION

WITHDRAWN

DISCONTINUED

NDA206995

ANDA211826

ACTIVE SUBSTANCE

Gefitinib

REGULATORS

FDA · EMA

SPONSORS / MAH

AstraZeneca AB, CIPLA, ASTRAZENECA

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
GEFITINIB	ANDA209532	APOTEX	Discontinued
IRESSA	NDA021399	ASTRAZENECA	Discontinued
IRESSA	NDA206995	ASTRAZENECA	Prescription
GEFITINIB	ANDA211826	CIPLA	Prescription

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Gefitinib Mylan	Mylan Pharmaceuticals Limited	Withdrawn	27/09/2018	Carcinoma, Non-Small-Cell Lung
Iressa	AstraZeneca AB	Authorised	24/06/2009	Carcinoma, Non-Small-Cell Lung

FULL INTELLIGENCE ON GEFITINIB