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 a supplemental FDA approval record documenting a REMS (Risk Evaluation and Mitigation Strategy) action for morphine sulfate extended-release tablets (30 mg, 60 mg, 100 mg, and 200 mg formulations) by RISING, approved 18 June 2026. The record contains no clinical trial results, efficacy data, or safety outcomes; it is a regulatory status document only.

What was studied

Regulatory label update.

Key findings

REMS supplement approval for morphine sulfate extended-release tablets in four strengths: 30 mg, 60 mg, 100 mg, and 200 mg Approval granted 18 June 2026 by FDA for ANDA 200824

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No comparative or absolute efficacy or safety measures are reported.

Who this may help

This regulatory approval does not support clinical decision-making or efficacy assessment. Clinicians should refer to the underlying product labeling and REMS requirements for prescribing guidance.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release tablets; regulatory action record without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Application numberANDA200824

Approval date2026-06-18

Product strengths approved30 mg, 60 mg, 100 mg, 200 mg

Clinical bottom line

This regulatory approval does not support clinical decision-making or efficacy assessment. Clinicians should refer to the underlying product labeling and REMS requirements for prescribing guidance.

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative or absolute efficacy or safety measures are reported.
REMS requirements and their specific content are not detailed in this record.
The record is a regulatory status notification only and does not substitute for clinical evidence.

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; not a clinical study.

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

Single regulatory action; no comparative or replicative data.

Risk of bias

insufficient

Not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No clinical population studied in this record.

Source abstract

Drugs@FDA record for application ANDA200824. This is a regulatory action record, not a clinical study. Brand name: MORPHINE SULFATE. Active ingredient: MORPHINE SULFATE. Sponsor: RISING. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: MORPHINE SULFATE, TABLET, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 100MG; MORPHINE SULFATE, TABLET, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 30MG; MORPHINE SULFATE, TABLET, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 200MG; MORPHINE SULFATE, TABLET, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 60MG.

Follow from this

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

RisingMorphine Sulfate