Guidance for Industry on Labeling Over-the-Counter Human Drug Products-Updating Labeling in Reference Listed Drugs and Abbreviated New Drug Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Labeling OTC Human Drug Products--Updating Labeling in RLDs and ANDAs." The guidance is intended to assist manufacturers of over-the-counter (OTC) reference listed drugs (RLDs) and manufacturers, packers, and distributors of OTC drug products marketed under abbreviated new drug applications (ANDAs) to implement the agency's regulation on standardized content and format requirements for the labeling of these products.