Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications; Correction

Summary

The FDA is correcting a notice that incorrectly stated the withdrawal of approval of 216 abbreviated new drug applications, including ANDA 075941, which was withdrawn due to repeated failure to submit annual reports. The FDA has now rescinded its withdrawal of approval for ANDA 075941, as the application holder had submitted annual reports.