Codeine Sulfate · Regulatory label update

FDA supplemental approval: Codeine Sulfate (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval for codeine sulfate tablets under a Risk Evaluation and Mitigation Strategy (REMS) program. The record documents regulatory classification and approved product strengths but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Approved formulations: codeine sulfate tablets 15 mg, 30 mg, and 60 mg oral Sponsor: Lannett Co Inc Submission class: REMS (Risk Evaluation and Mitigation Strategy)

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No comparative efficacy or adverse event data is reported.

Who this may help

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

Plain-language summary

FDA supplemental approval action for codeine sulfate REMS program; describes regulatory classification and product specifications without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Approved product strengths15 mg, 30 mg, 60 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative efficacy or adverse event data is reported.
REMS approval indicates risk mitigation requirements but specific restrictions or monitoring requirements are not detailed in this record.
The record does not establish clinical indications, dosing recommendations, or contraindications.

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 present.

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative or replication data provided in this record.

Risk of bias

insufficient

Not applicable; regulatory approval record without trial methodology.

Sample adequacy

insufficient

No clinical sample or population studied in this regulatory action.

Source abstract

Drugs@FDA record for application ANDA203046. This is a regulatory action record, not a clinical study. Brand name: CODEINE SULFATE. Active ingredient: CODEINE SULFATE. Sponsor: LANNETT CO INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: CODEINE SULFATE, TABLET, ORAL, CODEINE SULFATE 60MG; CODEINE SULFATE, TABLET, ORAL, CODEINE SULFATE 15MG; CODEINE SULFATE, TABLET, ORAL, CODEINE SULFATE 30MG.

Follow from this

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

Lannett COCodeine Sulfate