Orange Book FR Safety or Effectiveness Determinations List

The following is a list of approved drug products that have had Federal Register Citizen Petition Notices stating that the FDA has determined that the approved drug product was not discontinued for safety or effectiveness reasons. Under § 314.161(a)(1) [21 CFR 314.161(a)(1)], the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. The Federal Register Notice will allow FDA to approve applications (ANDAs) for the product if all other legal and regulatory requirements are met.