Ibuprofen AND Famotidine · Regulatory label update

FDA supplemental approval: Ibuprofen AND Famotidine (Labeling)

U.S. Food and Drug Administration · July 16, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval for labeling of a fixed-dose combination tablet containing ibuprofen 800 mg and famotidine 26.6 mg, approved on 16 July 2026. The record documents a regulatory labeling action by ANDA and does not report clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update.

Key findings

Safety

No clinical trial data, comparative evidence, or safety/efficacy outcomes are reported in this record.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of a fixed-dose combination product; regulatory action does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Ibuprofen dose800 mg

Famotidine dose26.6 mg

Approval date2026-07-16

Caveats

This is a regulatory labeling supplement, not a clinical trial or efficacy study.
No clinical trial data, comparative evidence, or safety/efficacy outcomes are reported in this record.
The record does not indicate whether approval was based on new clinical data or administrative/labeling changes only.
No information on indication, patient population studied, or clinical outcomes is 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

This is a regulatory action, not a clinical study.

Directness

insufficient

No clinical outcomes or comparative data reported in this record.

Consistency

insufficient

Single regulatory submission; no comparative evidence provided.

Risk of bias

insufficient

Regulatory record does not report trial conduct or bias assessment.

Sample adequacy

insufficient

No patient population or sample size reported in this record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA211890. This is a regulatory action record, not a clinical study. Brand name: IBUPROFEN AND FAMOTIDINE. Active ingredient: IBUPROFEN AND FAMOTIDINE. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-16. Products: IBUPROFEN AND FAMOTIDINE, TABLET, ORAL, FAMOTIDINE 26.6MG + IBUPROFEN 800MG.

Follow from this

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

Ibuprofen AND FamotidineAlkem Labs