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Dextrose Monohydrate · Regulatory label update
U.S. Food and Drug Administration · June 11, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a U.S. FDA supplemental approval record for a labeling change to dextrose monohydrate injectable products. The record documents a regulatory action (approval of labeling modifications) but does not contain clinical trial results, efficacy data, or safety outcomes.
Regulatory label update.
Supplemental approval granted for dextrose 5% in plastic container, injectable formulations (50 mg/mL and 5 g/100 mL)
This record is a labeling approval action and does not contain clinical trial results, efficacy data, or safety efficacy comparisons. No information on clinical outcomes, adverse events, or comparative benefit is provided.
The source did not state who this applies to in practice.
FDA supplemental approval for dextrose labeling; describes a regulatory action, not clinical evidence of efficacy or safety.
Quoted from the source exactly as published.
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.
Drugs@FDA record for application NDA016673. 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 5% IN PLASTIC CONTAINER, INJECTABLE, INJECTION, DEXTROSE 50MG/ML; DEXTROSE 5% IN PLASTIC CONTAINER, INJECTABLE, INJECTION, DEXTROSE 5GM/100ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.