Losartan Potassium AND Hydrochlorothiazide · Regulatory approval

FDA approval: Losartan Potassium AND Hydrochlorothiazide

U.S. Food and Drug Administration · May 27, 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 abbreviated new drug application (ANDA) for three fixed-dose combinations of losartan potassium and hydrochlorothiazide tablets. This approval record does not contain clinical trial results, efficacy data, or safety comparisons; it confirms only that the sponsor (Hetero Labs Ltd) met regulatory standards for bioequivalence and manufacturing.

What was studied

Regulatory approval.

Key findings

Three tablet strengths approved: 50 mg losartan + 12.5 mg HCTZ; 100 mg losartan + 12.5 mg HCTZ; 100 mg losartan + 25 mg HCTZ Approval date: 27 May 2026 Application type: original ANDA (generic drug)

Safety

This regulatory record does not contain clinical trial results, efficacy data, safety data, or bioequivalence study details. No information on comparative effectiveness, adverse events, or clinical outcomes is provided.

Who this may help

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

Plain-language summary

FDA approval of a generic fixed-dose combination of losartan potassium and hydrochlorothiazide; this is a regulatory action, not a clinical trial, and does not contain efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-27

Application typeANDA (Abbreviated New Drug Application)

Caveats

This regulatory record does not contain clinical trial results, efficacy data, safety data, or bioequivalence study details.
Approval implies the generic product met FDA standards for bioequivalence to the reference brand; specific bioequivalence metrics are not reported in this document.
No information on comparative effectiveness, adverse events, or clinical outcomes is provided.
The record does not specify the patient population for which this combination is indicated.

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

This is a regulatory record, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative or efficacy data provided in approval record.

Risk of bias

insufficient

This is a regulatory document, not a controlled trial.

Sample adequacy

insufficient

No sample size or study population data reported.

Source abstract

Drugs@FDA record for application ANDA219869. This is a regulatory action record, not a clinical study. Brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE. Active ingredient: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE. Sponsor: HETERO LABS LTD V. Submission type: ORIG (original application). Approval status date: 2026-05-27. Products: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 12.5MG + LOSARTAN POTASSIUM 100MG; LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 25MG + LOSARTAN POTASSIUM 100MG; LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, TABLET, ORAL, HYDROCHLOROTHIAZIDE 12.5MG + LOSARTAN POTASSIUM 50MG.

Follow from this

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

Hetero Labs LTD VLosartan Potassium AND Hydrochlorothiazide