Morphine Sulfate · Regulatory label update

FDA supplemental approval: Morphine 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 action for morphine sulfate tablet formulations (15 mg and 30 mg oral tablets) under a Risk Evaluation and Mitigation Strategy (REMS) program, granted to Ingenus Pharms NJ on 18 June 2026. The record does not contain clinical trial data, efficacy endpoints, or comparative safety information; it reflects a regulatory decision on risk management requirements for the product.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental application ANDA215584 for morphine sulfate REMS on 2026-06-18 Approval covers morphine sulfate 15 mg and 30 mg oral tablets Applicant: Ingenus Pharms NJ

Safety

This is a regulatory approval record and does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence. Applicant: Ingenus Pharms NJ

Who this may help

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

Plain-language summary

FDA supplemental approval action for morphine sulfate REMS program; establishes risk management requirements but does not report clinical trial efficacy or comparative outcomes.

Reported figures

Quoted from the source exactly as published.

Application numberANDA215584

Approval date2026-06-18

Formulations approvedMorphine sulfate 15 mg oral tablet; Morphine sulfate 30 mg oral tablet

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
The record does not specify the scope or contents of the REMS program.
No information on patient population, dosing indications, or clinical endpoints is provided.

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; no study design applicable to this record type.

Directness

insufficient

This is a regulatory approval, not a clinical evidence source.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed.

Risk of bias

insufficient

Not applicable to regulatory approval records.

Sample adequacy

insufficient

No patient cohort or sample reported in this record.

Source abstract

Drugs@FDA record for application ANDA215584. This is a regulatory action record, not a clinical study. Brand name: MORPHINE SULFATE. Active ingredient: MORPHINE SULFATE. Sponsor: INGENUS PHARMS NJ. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: MORPHINE SULFATE, TABLET, ORAL, MORPHINE SULFATE 15MG; MORPHINE SULFATE, TABLET, ORAL, MORPHINE SULFATE 30MG.

Follow from this

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

Morphine SulfateIngenus Pharms NJ