BENEMID is an oral tablet (product number 004) containing 500 mg of probenecid. The product is listed as a reference drug and its marketing status is marked as discontinued. A Federal Register determination notes that the discontinuation was not due to safety or effectiveness concerns.
The FDA record includes a series of priority supplemental submissions (SUPPL) covering labeling, manufacturing (CMC), REMS, and supplement categories. Submission dates range from 1976 to 1994, with submission numbers such as 1 (original Type 1 New Molecular Entity filing on 1951‑04‑26) and later numbers 14, 16, 18, 22, 26, 30, 32, 36, 40, 42. All listed submissions have a status of AP (approved).
規制動向2026年9月16日•3分で読めます
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.
Pharmacountryチームがまとめました · 出典： FDA.gov
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