Gabapentin · Regulatory approval

FDA approval: Gabapentin

U.S. Food and Drug Administration · June 23, 2026

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The material analysed did not support any firm read.

AI Summary

The FDA approved ANDA 203611 for gabapentin 300 mg and 600 mg tablets (Actavis Elizabeth) on June 23, 2026. This is a regulatory action authorizing marketing of a generic formulation and does not report clinical trial results, comparative efficacy, or safety data.

What was studied

Regulatory approval. Intervention: Gabapentin 300 mg tablet, oral; Gabapentin 600 mg tablet, oral.

Key findings

Approval granted for gabapentin 300 mg and 600 mg oral tablets under ANDA 203611

Safety

This record does not contain clinical trial results, efficacy data, safety data, or comparative evidence.

Who this may help

This record confirms FDA authorization of the specified gabapentin generic product for marketing in the United States. Clinicians should consult approved labeling and prior clinical evidence for the pharmacology and use of gabapentin; this approval record does not provide that information.

Plain-language summary

This is an FDA approval record for a generic gabapentin formulation; it documents regulatory authorization but contains no clinical trial data or efficacy evidence.

Study design

As stated by the source record.

InterventionGabapentin 300 mg tablet, oral; Gabapentin 600 mg tablet, oral

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-23

Formulation strengths300 mg, 600 mg

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety data, or comparative evidence.
No information on bioequivalence study design, sample size, or comparative arms is provided.
Approval indicates regulatory compliance with manufacturing and bioequivalence standards but does not address clinical outcomes.

Evidence assessment

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.

Study design

insufficient

Regulatory record; no study design present.

Directness

insufficient

Approval document does not report clinical outcomes.

Consistency

insufficient

Single regulatory action; no comparative data reported.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical study population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA203611. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: ACTAVIS ELIZABETH. Submission type: ORIG (original application). Approval status date: 2026-06-23. Products: GABAPENTIN, TABLET, ORAL, GABAPENTIN 600MG; GABAPENTIN, TABLET, ORAL, GABAPENTIN 300MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Actavis ElizabethGabapentin