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Gabapentin · Regulatory label update
U.S. Food and Drug Administration · May 1, 2026
An action by a regulator. Authoritative on labelling and availability.
This record documents an FDA supplemental approval for gabapentin labeling changes by Zhejiang Yongtai, effective 1 May 2026, covering 100 mg, 300 mg, and 400 mg oral capsule formulations. The action itself is regulatory and does not include clinical trial results, efficacy data, or safety outcomes.
Regulatory label update.
This record documents an FDA supplemental approval for gabapentin labeling changes by Zhejiang Yongtai, effective 1 May 2026, covering 100 mg, 300 mg, and 400 mg oral capsule formulations. The action itself is regulatory and does not include clinical trial results, efficacy data, or safety outcomes.
This record does not contain clinical trial results, efficacy data, or safety outcomes.
The source did not state who this applies to in practice.
This is an FDA supplemental approval action for gabapentin labeling; it documents a regulatory decision but does not report clinical trial data or efficacy outcomes.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA213603. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: ZHEJIANG YONGTAI. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-01. Products: GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 400MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 100MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 300MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.