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2026-09-29 · Notice · Federal Register document 2026-19921

Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Official abstract: The Food and Drug Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) tablet, 500 mg, if all other legal and regulatory requirements are met.

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