Morphine Sulfate · Regulatory label update

FDA supplemental approval: Morphine Sulfate (REMS)

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

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AI Summary

This is a regulatory approval action by the FDA granting supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release capsules (20 mg, 50 mg, 80 mg, and 100 mg) submitted by Strides Pharma International on application ANDA200812, approved on 18 June 2026. This record does not contain clinical trial results, efficacy data, or comparative safety outcomes; it establishes regulatory requirements for the safe distribution and use of the product.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory approval record, not a clinical trial; no efficacy, safety, or comparative data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release capsules; this is a regulatory action establishing safety management requirements, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Application numberANDA200812

Formulations approved20 mg, 50 mg, 80 mg, 100 mg extended-release oral capsules

Caveats

This is a regulatory approval record, not a clinical trial; no efficacy, safety, or comparative data are reported.
REMS approval indicates a risk management strategy but does not provide clinical trial results or outcome measures.
No sample size, study population, endpoints, or statistical analyses are provided in this record.
Approval of a REMS does not constitute evidence of clinical superiority or efficacy compared to other formulations or products.

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 record; no clinical study design reported.

Directness

insufficient

REMS approval record; does not report clinical trial outcomes or direct efficacy data.

Consistency

insufficient

Single regulatory action; consistency assessment not applicable.

Risk of bias

insufficient

Regulatory approval; no clinical trial bias assessment relevant.

Sample adequacy

insufficient

No study population or sample size; regulatory record only.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA200812. This is a regulatory action record, not a clinical study. Brand name: MORPHINE SULFATE. Active ingredient: MORPHINE SULFATE. Sponsor: STRIDES PHARMA INTL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: MORPHINE SULFATE, CAPSULE, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 80MG; MORPHINE SULFATE, CAPSULE, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 50MG; MORPHINE SULFATE, CAPSULE, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 20MG; MORPHINE SULFATE, CAPSULE, EXTENDED RELEASE, ORAL, MORPHINE SULFATE 100MG.

Follow from this

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

Morphine SulfateStrides Pharma Intl