Prescription Drug Products; Levothyroxine Sodium; Extension of Compliance Date

摘要

The Food and Drug Administration (FDA) is announcing that manufacturers who were marketing orally administered drug products containing levothyroxine sodium on or before August 14, 1997, may continue to market these products without approved applications until August 14, 2001. FDA is extending by 1 year the compliance date given in the notice published in the Federal Register of August 14, 1997 (62 FR 43535). The agency is taking this action to give manufacturers additional time to conduct studies and to prepare applications.