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US Federal Register - FDA Notices · United States · 14 Aug 2026 · Approval & opinion

Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that ANSAID (flurbiprofen) tablets, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurbiprofen tablets, 50 mg and 100 mg, if all other legal and regulatory requirements are met.