Cefazolin Sodium · Regulatory label update

FDA supplemental approval: Cefazolin (Labeling)

U.S. Food and Drug Administration · August 31, 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 regulatory record documenting FDA approval of a labeling supplement for cefazolin sodium intravenous formulations in dextrose, approved on 31 August 2026. The record contains no clinical trial results, efficacy data, or comparative evidence; it documents only the regulatory action and affected product formulations.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for cefazolin in dextrose formulations: 1 g/50 mL, 2 g/100 mL, and 3 g/150 mL (20 mg/mL base)

Safety

No safety or efficacy endpoints, sample sizes, or outcome measures are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for cefazolin formulations; no clinical trial data or efficacy evidence is reported in this regulatory record.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-31

Caveats

This record does not contain clinical trial results, efficacy data, or comparative benefit evidence.
The specific content of the labeling changes is not detailed in this regulatory record.
No safety or efficacy endpoints, sample sizes, or outcome measures are reported.
Approval classification is labeling only; no new indication, formulation composition change, or clinical data submission is described.

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 study design applicable.

Directness

insufficient

Record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative data or consistency assessment provided.

Risk of bias

insufficient

Regulatory document; bias assessment not applicable.

Sample adequacy

insufficient

No human subjects or sample size; regulatory approval action only.

Source abstract

Drugs@FDA record for application NDA207131. This is a regulatory action record, not a clinical study. Brand name: CEFAZOLIN. Active ingredient: CEFAZOLIN SODIUM. Sponsor: BAXTER HLTHCARE CORP. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-31. Products: CEFAZOLIN IN DEXTROSE, SOLUTION, INTRAVENOUS, CEFAZOLIN SODIUM EQ 1GM BASE/50ML (EQ 20MG BASE/ML); CEFAZOLIN IN DEXTROSE, SOLUTION, INTRAVENOUS, CEFAZOLIN SODIUM EQ 3GM BASE/150ML (EQ 20MG BASE/ML); CEFAZOLIN IN DEXTROSE, SOLUTION, INTRAVENOUS, CEFAZOLIN SODIUM EQ 2GM BASE/100ML (EQ 20MG BASE/ML).

Follow from this

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

Cefazolin SodiumBaxter Hlthcare