Watson Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets

الملخص

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets. The basis for the withdrawal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA. The holder of the ANDA has waived its opportunity for a hearing.