ACTIVE SUBSTANCE / INN

TOLBUTAMIDE

Brand name(s): TOLBUTAMIDE, ORINASE

FDA LISTED

DISCONTINUED

NDA010670

ANDA086445

ACTIVE SUBSTANCE

Tolbutamide

REGULATORS

FDA

SPONSORS / MAH

PHARMOBEDIENT, PHARMACIA AND UPJOHN

TOTAL APPLICATIONS

2

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
TOLBUTAMIDE	ANDA086445	PHARMOBEDIENT	Discontinued
ORINASE	NDA010670	PHARMACIA AND UPJOHN	Discontinued