Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams

摘要

The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 062247 for chloramphenicol capsules, 250 milligrams (mg), held by Ivax Pharmaceuticals, Inc. (Ivax). Ivax requested withdrawal of this application and has waived its opportunity for a hearing.