Losartan Potassium · Regulatory label update

FDA supplemental approval: Losartan Potassium 25 MG (Labeling)

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

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a U.S. Food and Drug Administration supplemental approval for labeling changes to losartan potassium 25 mg tablets (ANDA090382) granted to Strides Pharma on 8 June 2026. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for labeling of losartan potassium 25 mg, 50 mg, and 100 mg tablets on 2026-06-08

Safety

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

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for labeling of a generic losartan potassium formulation; it documents a regulatory decision, not clinical trial evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-08

Application numberANDA090382

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No information is provided about the specific labeling changes made.
No comparative data, sample sizes, or statistical analyses are reported.
Regulatory approval of labeling does not imply or document clinical superiority or new efficacy claims.

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 labeling approval does not report clinical outcome data.

Consistency

insufficient

No comparative or confirmatory clinical data presented in this record.

Risk of bias

insufficient

Regulatory approval record does not contain trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical trial population or sample size reported in this labeling submission.

Source abstract

Drugs@FDA record for application ANDA090382. This is a regulatory action record, not a clinical study. Brand name: LOSARTAN POTASSIUM 25 MG. Active ingredient: LOSARTAN POTASSIUM. Sponsor: STRIDES PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-08. Products: LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 50MG; LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 100MG; LOSARTAN POTASSIUM, TABLET, ORAL, LOSARTAN POTASSIUM 25MG.

Follow from this

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

Strides PharmaLosartan Potassium