Federal brief
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Publisher-desk brief on Food and Drug Administration FR 2026-19921 (2026-09-29). Use the filing for dates and comment paths.
FDA determined an old sulfadiazine tablet ANDA reference is gone from the market — a small sentence with big generic-substitution consequences.
"Determination that…" notices are how the Agency retires a reference listed drug when nobody is left manufacturing it; pharmacists feel it at the counter.
Filing abstract (agency text): 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Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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.
Hospital pharmacy and ANDA sponsors: verify strength, dosage form, and therapeutic-equivalence implications in the FR determination before you update formularies.
Federal Register filing: https://www.federalregister.gov/documents/2026/09/29/2026-19921/determination-that-sulfadiazine-sulfadiazine-tablet-500-milligrams-was-not-withdrawn-from-sale-for
This is a Notice Nearby publisher-desk Federal brief — a short in-house summary of a public federal filing. It is not official agency minutes, not a newspaper story, and not Legal Publication. It does not satisfy a statutory notice requirement.
Source: the official public federal record 2026-19921 · Federal Register · 2026-19921 · 2026-19921.
This is a Notice Nearby publisher-desk Federal brief — a short in-house summary of a public federal filing. It is not official agency minutes, not a newspaper story, and not Legal Publication. It does not satisfy a statutory notice requirement.