Labetalol Hydrochloride · Regulatory label update

FDA supplemental approval: Labetalol Hydrochloride (Labeling)

U.S. Food and Drug Administration · June 8, 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 regulatory action record documenting FDA approval of a supplemental labeling change for labetalol hydrochloride tablets (100 mg, 200 mg, and 300 mg oral formulations) submitted by Epic Pharma LLC. The record does not contain clinical trial data, efficacy results, or safety evidence; it confirms only that a labeling revision was approved on 8 June 2026.

What was studied

Regulatory label update.

Key findings

FDA approval of labeling supplement for labetalol hydrochloride tablets granted 8 June 2026 Three strengths approved: 100 mg, 200 mg, and 300 mg oral tablets

Safety

This is a regulatory approval record; no clinical trial results, efficacy data, safety data, or comparative evidence are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for labetalol hydrochloride tablets; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-08

Application numberANDA212990

Caveats

This is a regulatory approval record; no clinical trial results, efficacy data, safety data, or comparative evidence are reported.
The specific labeling changes approved are not detailed in this source.
No information on mechanism, indication, contraindication, or clinical outcome measures.
Record confirms submission acceptance and labeling revision authority only.

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 present.

Directness

insufficient

Labeling approval; clinical outcomes not reported or assessed.

Consistency

insufficient

Single regulatory action; no comparative or replicative data.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample; regulatory submission record only.

Source abstract

Drugs@FDA record for application ANDA212990. This is a regulatory action record, not a clinical study. Brand name: LABETALOL HYDROCHLORIDE. Active ingredient: LABETALOL HYDROCHLORIDE. Sponsor: EPIC PHARMA LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-08. Products: LABETALOL HYDROCHLORIDE, TABLET, ORAL, LABETALOL HYDROCHLORIDE 200MG; LABETALOL HYDROCHLORIDE, TABLET, ORAL, LABETALOL HYDROCHLORIDE 300MG; LABETALOL HYDROCHLORIDE, TABLET, ORAL, LABETALOL HYDROCHLORIDE 100MG.

Follow from this

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

Epic PharmaLabetalol Hydrochloride