Risedronate Sodium · Regulatory label update

FDA supplemental approval: Risedronate Sodium (Labeling)

U.S. Food and Drug Administration · June 8, 2026

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AI Summary

This is an FDA supplemental approval record for labeling of generic risedronate sodium tablets (5 mg, 30 mg, and 35 mg) manufactured by Aurobindo Pharma Ltd, approved on 8 June 2026. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental labeling for risedronate sodium tablets in three strengths: 5 mg, 30 mg, and 35 mg oral tablets

Safety

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

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental labeling approval for generic risedronate sodium; regulatory action does not contain clinical efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-08

ANDA application numberANDA200296

Submission classLabeling

Caveats

This record does not contain clinical trial results, efficacy outcomes, or comparative safety data.
Approval of labeling does not indicate new clinical evidence or practice changes.
No study population, endpoint data, or statistical analyses are reported.

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

Labeling approval record; does not report clinical trial outcomes.

Consistency

insufficient

Single regulatory action; no comparative or multiple studies cited.

Risk of bias

insufficient

Not applicable to regulatory labeling submission record.

Sample adequacy

insufficient

No human subjects study data reported in this record.

Source abstract

Drugs@FDA record for application ANDA200296. This is a regulatory action record, not a clinical study. Brand name: RISEDRONATE SODIUM. Active ingredient: RISEDRONATE SODIUM. Sponsor: AUROBINDO PHARMA LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-08. Products: RISEDRONATE SODIUM, TABLET, ORAL, RISEDRONATE SODIUM 35MG; RISEDRONATE SODIUM, TABLET, ORAL, RISEDRONATE SODIUM 5MG; RISEDRONATE SODIUM, TABLET, ORAL, RISEDRONATE SODIUM 30MG.

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

Aurobindo PharmaRisedronate Sodium