Guidance for Industry on Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate-Labeling Enforcement Policy; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate--Labeling Enforcement Policy." This guidance discusses how FDA plans to exercise its enforcement discretion after September 1, 2002, with regard to drug products whose labeling does not use the established names for ensulizole, hypromellose, meradimate, octinoxate, and octisalate.