Verapamil Hydrochloride · Regulatory label update

FDA supplemental approval: Verapamil Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 1, 2026

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AI Summary

The FDA approved a supplemental labeling change for verapamil hydrochloride extended-release capsules (100 mg, 200 mg, 300 mg) on 1 July 2026. This regulatory record documents an administrative action and does not contain or report clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval for verapamil hydrochloride labeling; this is a regulatory action record without clinical trial data and does not establish efficacy or comparative benefit.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-01

Application numberANDA078306

Dosage strengths approved100 mg, 200 mg, 300 mg extended-release capsules

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The nature of the labeling change is not specified in this regulatory record.
No comparator, control group, or comparative efficacy information is provided.
No patient population, sample size, or clinical endpoints 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 clinical study design reported.

Directness

insufficient

Labeling supplement; clinical outcomes not reported.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory labeling action.

Sample adequacy

insufficient

No trial population or sample size reported.

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 ANDA078306. This is a regulatory action record, not a clinical study. Brand name: VERAPAMIL HYDROCHLORIDE. Active ingredient: VERAPAMIL HYDROCHLORIDE. Sponsor: RISING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-01. Products: VERAPAMIL HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, VERAPAMIL HYDROCHLORIDE 200MG; VERAPAMIL HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, VERAPAMIL HYDROCHLORIDE 300MG; VERAPAMIL HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, VERAPAMIL HYDROCHLORIDE 100MG.

Follow from this

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

RisingVerapamil Hydrochloride