Guidance for Industry on Levothyroxine Sodium Products-Enforcement of August 14, 2001, Compliance Date and Submission of New Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Levothyroxine Sodium Products--Enforcement of August 14, 2001, Compliance Date and Submission of New Applications." This guidance discusses how FDA plans to exercise its enforcement discretion after August 14, 2001, with regard to levothyroxine sodium products that are marketed without approved applications. This guidance also answers certain frequently asked questions concerning the submission of applications for levothyroxine sodium products. It replaces the previously issued guidance entitled "Levothyroxine Sodium, Questions and Answers" (February 2001).