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Prochlorperazine Edisylate · Regulatory label update
U.S. Food and Drug Administration · April 1, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a supplemental FDA approval for a labeling change to prochlorperazine edisylate injectable (5 mg/mL) under ANDA 212257, approved on 1 April 2026. The record does not report clinical trial outcomes, efficacy data, or safety findings; it documents only a regulatory labeling action by the FDA.
Regulatory label update.
This is a supplemental FDA approval for a labeling change to prochlorperazine edisylate injectable (5 mg/mL) under ANDA 212257, approved on 1 April 2026. The record does not report clinical trial outcomes, efficacy data, or safety findings; it documents only a regulatory labeling action by the FDA.
This is a regulatory record and does not contain clinical trial results, efficacy data, or safety evidence.
The source did not state who this applies to in practice.
FDA supplemental approval for labeling update to prochlorperazine edisylate injectable; this is a regulatory action, not a clinical trial, and does not contain efficacy or safety evidence.
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.
What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA212257. This is a regulatory action record, not a clinical study. Brand name: PROCHLORPERAZINE EDISYLATE. Active ingredient: PROCHLORPERAZINE EDISYLATE. Sponsor: SOMERSET THERAPS LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-01. Products: PROCHLORPERAZINE EDISYLATE, INJECTABLE, INJECTION, PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.