Vasopressin · Regulatory approval

FDA approval: Vasopressin

U.S. Food and Drug Administration · May 6, 2026

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AI Summary

This is a regulatory approval record documenting FDA acceptance of an ANDA for a generic vasopressin 20 units/mL intravenous solution from Sandoz, approved on 6 May 2026. The record itself contains no clinical trial results, efficacy data, safety outcomes, or comparative evidence; it is a registration milestone only.

What was studied

Regulatory approval. Intervention: Vasopressin 20 units/mL, intravenous solution.

Key findings

ANDA212068 approved as original application for vasopressin solution, intravenous formulation Product strength: 20 units/mL Sponsor: Sandoz

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No information on indication, dosing recommendations, contraindications, or adverse events in this approval notice.

Who this may help

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

Plain-language summary

FDA approval of a generic vasopressin formulation; regulatory milestone with no clinical trial data in this record.

Study design

As stated by the source record.

InterventionVasopressin 20 units/mL, intravenous solution

Reported figures

Quoted from the source exactly as published.

Product strength20 units/mL

Approval date2026-05-06

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative bioavailability or bioequivalence data reported in this regulatory record.
No information on indication, dosing recommendations, contraindications, or adverse events in this approval notice.
ANDA approval implies bioequivalence to a reference product but does not report the underlying evidence in this record.

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 approval record; no clinical study design reported.

Directness

insufficient

Record contains no clinical efficacy or safety data.

Consistency

insufficient

No comparative data or study outcomes reported in this record.

Risk of bias

insufficient

Regulatory record does not report clinical trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or patient population data in this record.

Source abstract

Drugs@FDA record for application ANDA212068. This is a regulatory action record, not a clinical study. Brand name: VASOPRESSIN. Active ingredient: VASOPRESSIN. Sponsor: SANDOZ. Submission type: ORIG (original application). Approval status date: 2026-05-06. Products: VASOPRESSIN, SOLUTION, INTRAVENOUS, VASOPRESSIN 20UNITS/ML (20UNITS/ML).

Follow from this

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

SandozVasopressin