Loading
Gabapentin · Regulatory label update
U.S. Food and Drug Administration · April 2, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval action for labeling changes to gabapentin capsules (100 mg, 300 mg, 400 mg) by Strides Pharma, approved on 2 April 2026. The record does not contain clinical trial data, efficacy results, or safety findings; it documents only a regulatory decision to modify product labeling.
Regulatory label update.
This is an FDA supplemental approval action for labeling changes to gabapentin capsules (100 mg, 300 mg, 400 mg) by Strides Pharma, approved on 2 April 2026. The record does not contain clinical trial data, efficacy results, or safety findings; it documents only a regulatory decision to modify product labeling.
Record does not contain clinical trial results, efficacy data, or safety evidence.
The source did not state who this applies to in practice.
FDA supplemental approval for gabapentin labeling changes; describes a regulatory action, not clinical evidence of efficacy or safety.
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 ANDA206943. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: STRIDES PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-02. 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.