Magnesium Sulfate · Regulatory approval

FDA approval: Sodium Sulfate, Magnesium Sulfate AND Potassium Chloride

U.S. Food and Drug Administration · May 28, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a generic formulation of sodium sulfate, magnesium sulfate, and potassium chloride tablets (ANDA application) on 28 May 2026. This is a regulatory action record only and does not report clinical trial results, efficacy, or comparative benefit.

What was studied

Regulatory approval.

Key findings

FDA approval granted for ANDA216095 on 2026-05-28 Product composition: MAGNESIUM SULFATE 0.225GM + POTASSIUM CHLORIDE 0.188GM + SODIUM SULFATE 1.479GM per tablet Sponsor: Lupin; submission type: original application

Safety

No safety, tolerability, or patient population information is reported.

Who this may help

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

Plain-language summary

FDA approval of a generic bowel preparation combination; regulatory action record without clinical trial data or efficacy comparison.

Reported figures

Quoted from the source exactly as published.

Magnesium sulfate dose per tablet0.225GM

Potassium chloride dose per tablet0.188GM

Sodium sulfate dose per tablet1.479GM

Approval date2026-05-28

Caveats

This record does not contain or report clinical trial results, efficacy data, or comparative outcomes.
Approval under the ANDA pathway indicates bioequivalence to a reference product, but comparative clinical data are not provided in this record.
No safety, tolerability, or patient population information is reported.
No study design, sample size, or endpoint data are available in this regulatory record.

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 approval record; no clinical study design reported.

Directness

insufficient

Record does not report clinical outcomes or efficacy measures.

Consistency

insufficient

Single approval record; no comparative efficacy data provided.

Risk of bias

insufficient

Regulatory approval based on ANDA pathway; no trial bias assessment.

Sample adequacy

insufficient

No clinical sample or trial population described.

Source abstract

Drugs@FDA record for application ANDA216095. This is a regulatory action record, not a clinical study. Brand name: SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE. Active ingredient: MAGNESIUM SULFATE. Sponsor: LUPIN. Submission type: ORIG (original application). Approval status date: 2026-05-28. Products: SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE, TABLET, ORAL, MAGNESIUM SULFATE 0.225GM + POTASSIUM CHLORIDE 0.188GM + SODIUM SULFATE 1.479GM.

Follow from this

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

LupinMagnesium Sulfate