Dextrose Monohydrate · Regulatory label update

FDA supplemental approval: Dextrose (Labeling)

U.S. Food and Drug Administration · June 11, 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 a labeling change to dextrose 10% injection (dextrose monohydrate, 10 g/100 mL in plastic container), approved on 11 June 2026. The record does not contain clinical trial data, efficacy endpoints, safety outcomes, or the nature of the labeling revision, and therefore carries no clinical evidence value.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No information on indication, dosing, contraindications, or adverse event findings is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to dextrose 10% injection; does not constitute clinical evidence of efficacy or safety.

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes made are not described in this record.
No information on indication, dosing, contraindications, or adverse event findings is provided.
Regulatory approval of labeling does not imply new clinical evidence or change in product efficacy profile.

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 study design present.

Directness

insufficient

Labeling change only; no clinical outcome data provided.

Consistency

insufficient

Single regulatory action; no comparative or replicated evidence.

Risk of bias

insufficient

Not applicable to regulatory submission record.

Sample adequacy

insufficient

No patient sample or trial population described.

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

Source abstract

Drugs@FDA record for application NDA016694. This is a regulatory action record, not a clinical study. Brand name: DEXTROSE. Active ingredient: DEXTROSE MONOHYDRATE. Sponsor: BAXTER HLTHCARE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-11. Products: DEXTROSE 10% IN PLASTIC CONTAINER, INJECTABLE, INJECTION, DEXTROSE 10GM/100ML.

Follow from this

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

Dextrose MonohydrateBaxter Hlthcare