ACTIVE SUBSTANCE / INN

FLUMAZENIL

Brand name(s): FLUMAZENIL, ROMAZICON

FDA LISTED

PRESCRIPTION

DISCONTINUED

ANDA076955

ANDA078595

ACTIVE SUBSTANCE

Flumazenil

REGULATORS

FDA

SPONSORS / MAH

HOFFMANN LA ROCHE, RISING, FRESENIUS KABI USA

TOTAL APPLICATIONS

3

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
FLUMAZENIL	ANDA076955	FRESENIUS KABI USA	Prescription
FLUMAZENIL	ANDA078595	RISING	Discontinued
ROMAZICON	NDA020073	HOFFMANN LA ROCHE	Discontinued