Drug or technology

Heparin Sodium

2 developments in the corpus

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JUL 13, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Heparin Sodium (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for heparin sodium injectable formulations; this is a regulatory action, not a clinical efficacy study.

Regulatory UpdateHeparin Sodium Hospira

Reported

Approval date2026-07-13

SponsorHOSPIRA INC.

Application numberANDA090571

JUL 9, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Heparin Sodium (Labeling)

U.S. Food and Drug Administration

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

Regulatory UpdateHeparin Sodium Hospira

Reported

Approval date2026-07-09

ANDA numberANDA089522

Approved product strengthHEPARIN SODIUM 10,000 UNITS/ML