Loading
Morphine Sulfate · Regulatory label update
U.S. Food and Drug Administration · May 29, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a U.S. FDA supplemental approval record for morphine sulfate labeling changes, approved on 29 May 2026. The record documents regulatory authorization but does not contain clinical trial results, efficacy data, or comparative outcomes. Clinicians should consult the updated product labeling and prescribing information for specific approved indications and safety profile changes.
Regulatory label update.
Supplemental approval granted for morphine sulfate labeling (NDA 204223) Four formulations approved: 4 mg/mL, 5 mg/mL, 8 mg/mL, and 10 mg/mL solutions for intramuscular and intravenous routes Sponsor: Fresenius Kabi USA; approval date 29 May 2026
No comparative outcomes, efficacy endpoints, or adverse event frequencies are reported.
This record is a regulatory action only and does not provide clinical evidence. Prescribers should refer to the updated product labeling, package insert, and FDA guidance documents for approved uses, dosing, contraindications, and safety information.
FDA supplemental approval of morphine sulfate labeling; regulatory action does not report clinical trial outcomes or efficacy data.
Quoted from the source exactly as published.
This record is a regulatory action only and does not provide clinical evidence. Prescribers should refer to the updated product labeling, package insert, and FDA guidance documents for approved uses, dosing, contraindications, and safety information.
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.
Drugs@FDA record for application NDA204223. This is a regulatory action record, not a clinical study. Brand name: MORPHINE SULFATE. Active ingredient: MORPHINE SULFATE. Sponsor: FRESENIUS KABI USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-29. Products: MORPHINE SULFATE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, MORPHINE SULFATE 8MG/ML (8MG/ML); MORPHINE SULFATE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, MORPHINE SULFATE 4MG/ML (4MG/ML); MORPHINE SULFATE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, MORPHINE SULFATE 10MG/ML (10MG/ML); MORPHINE SULFATE, SOLUTION, INTRAMUSCULAR, INTRAVENOUS, MORPHINE SULFATE 5MG/ML (5MG/ML).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.