Spironolactone AND Hydrochlorothiazide · Regulatory label update

FDA supplemental approval: Spironolactone AND Hydrochlorothiazide (Labeling)

U.S. Food and Drug Administration · May 12, 2026

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AI Summary

This is a supplemental FDA approval of labeling for a fixed-dose combination of spironolactone 25 mg and hydrochlorothiazide 25 mg (oral tablet), granted on 12 May 2026 to SUN PHARM INDUSTRIES. The record confirms regulatory authorization but contains no clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update. Intervention: Spironolactone 25 mg + hydrochlorothiazide 25 mg oral tablet.

Key findings

FDA supplemental approval granted for spironolactone 25 mg + hydrochlorothiazide 25 mg combination tablet formulation

Safety

Regulatory record does not contain clinical trial data or efficacy/safety results.

Who this may help

This regulatory record authorizes the labeled use of the combination product but does not provide evidence of clinical efficacy, safety outcomes, or comparative benefit. Clinicians should consult full prescribing information and published clinical literature for safety and efficacy evidence.

Plain-language summary

FDA supplemental labeling approval for a fixed-dose combination antihypertensive; regulatory authorization does not convey clinical efficacy evidence.

Study design

As stated by the source record.

InterventionSpironolactone 25 mg + hydrochlorothiazide 25 mg oral tablet

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-12

Spironolactone dose25 mg

Hydrochlorothiazide dose25 mg

Clinical bottom line

Caveats

Regulatory record does not contain clinical trial data or efficacy/safety results.
No population, sample size, or outcome measures reported.
Submission class is labeling only; underlying approval basis not disclosed in this record.
No comparator arm or baseline data provided.

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 action record; no clinical trial design described.

Directness

insufficient

Labeling submission; does not report clinical endpoints or comparative data.

Consistency

insufficient

Single regulatory record; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory approval does not assess or report trial bias metrics.

Sample adequacy

insufficient

No patient population or sample size data reported in regulatory record.

Source abstract

Drugs@FDA record for application ANDA089534. This is a regulatory action record, not a clinical study. Brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Active ingredient: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Sponsor: SUN PHARM INDUSTRIES. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-12. Products: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 25MG + SPIRONOLACTONE 25MG.

Follow from this

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

Spironolactone AND HydrochlorothiazideSUN Pharm Industries