Impax Laboratories, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Ursodiol Capsules USP, 300 Milligrams

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax Laboratories, LLC (Impax). Impax requested withdrawal of this application and has waived its opportunity for a hearing.