MK Laboratories, Inc., et al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications for Propoxyphene Products; Opportunity for a Hearing

الملخص

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) for propoxyphene drug products from multiple sources and is announcing an opportunity for holders of those ANDAs to request a hearing on this proposal.