Heparin Sodium · Regulatory label update

FDA supplemental approval: Heparin Sodium (Labeling)

U.S. Food and Drug Administration · July 9, 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. FDA supplemental approval record for a labeling change to heparin sodium 10,000 units/mL preservative-free injectable formulation (ANDA089522, sponsor Hospira), approved 9 July 2026. The record does not contain clinical trial results, efficacy data, or safety comparisons and therefore cannot support any inference about clinical benefit or harm.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy endpoints, safety data, or comparative information. No data on clinical outcomes, adverse events, or patient populations studied are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for heparin sodium labeling change; does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-09

ANDA numberANDA089522

Approved product strengthHEPARIN SODIUM 10,000 UNITS/ML

Caveats

This record does not contain clinical trial results, efficacy endpoints, safety data, or comparative information.
The nature of the labeling change is not described in this regulatory summary.
No data on clinical outcomes, adverse events, or patient populations studied are reported.

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

Labeling submission; no clinical outcome data provided.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed.

Risk of bias

insufficient

Not a clinical trial; risk of bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample; regulatory submission only.

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 ANDA089522. This is a regulatory action record, not a clinical study. Brand name: HEPARIN SODIUM. Active ingredient: HEPARIN SODIUM. Sponsor: HOSPIRA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-09. Products: HEPARIN SODIUM PRESERVATIVE FREE, INJECTABLE, INJECTION, HEPARIN SODIUM 10,000 UNITS/ML.

Follow from this

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

Heparin SodiumHospira