Methylphenidate Hydrochloride · Regulatory label update

FDA supplemental approval: Methylphenidate Hydrochloride (Labeling)

U.S. Food and Drug Administration · April 21, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental labeling change for methylphenidate hydrochloride extended-release capsules (10, 30, 50, and 60 mg) manufactured by IMPAX LABS INC on 21 April 2026. This is a regulatory action record that does not contain clinical trial data, efficacy findings, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental labeling approval granted for methylphenidate hydrochloride extended-release capsule formulation (ANDA205105) Available strengths: 10 mg, 30 mg, 50 mg, and 60 mg oral extended-release capsules

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 of labeling changes for an existing methylphenidate hydrochloride extended-release formulation; does not report clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-21

Approved strengths10 mg, 30 mg, 50 mg, 60 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The nature and scope of labeling changes are not specified in this document.
No comparator formulation or comparative evidence is reported.
This is an administrative approval record; it does not support clinical recommendations.

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 applicable.

Directness

insufficient

Labeling approval does not report clinical outcomes or evidence.

Consistency

insufficient

No comparative data or replication reported in this record.

Risk of bias

insufficient

Regulatory submission; bias assessment not applicable.

Sample adequacy

insufficient

No patient sample or clinical trial data reported.

Source abstract

Drugs@FDA record for application ANDA205105. This is a regulatory action record, not a clinical study. Brand name: METHYLPHENIDATE HYDROCHLORIDE. Active ingredient: METHYLPHENIDATE HYDROCHLORIDE. Sponsor: IMPAX LABS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-21. Products: METHYLPHENIDATE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, METHYLPHENIDATE HYDROCHLORIDE 50MG; METHYLPHENIDATE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, METHYLPHENIDATE HYDROCHLORIDE 30MG; METHYLPHENIDATE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, METHYLPHENIDATE HYDROCHLORIDE 10MG; METHYLPHENIDATE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL, METHYLPHENIDATE HYDROCHLORIDE 60MG.

Follow from this

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

Methylphenidate HydrochlorideImpax Labs