Business · 22/04/2005Updated: 10/17/2026 · 1 min read
FDA Corrects Withdrawal of Approval for 76 New Drug Applications and 60 Abbreviated New Drug Applications
Summary
The FDA is correcting a notice that withdrew approval of 76 new drug applications and 60 abbreviated new drug applications, including a mistake that incorrectly withdrew approval of Sotalol Hydrochloride Tablets by TorPharm, a subsidiary of Apotex Corp.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →