Methylene Blue · Regulatory label update

FDA supplemental approval: Methylene Blue (Manufacturing (CMC))

U.S. Food and Drug Administration · March 31, 2026

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AI Summary

This is a FDA supplemental approval for manufacturing and chemistry changes to methylene blue intravenous solutions (four formulations: 5 mg/mL, 10 mg/2 mL, 50 mg/10 mL, and 100 mg/10 mL), granted to sponsor Zydus Lifesciences on 31 March 2026. The record confirms regulatory approval of CMC (Chemistry, Manufacturing, and Controls) revisions but contains no clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Four methylene blue intravenous solution formulations approved: 5 mg/mL, 10 mg/2 mL, 50 mg/10 mL, and 100 mg/10 mL concentrations Supplemental approval granted 2026-03-31 for ANDA 215636 (generic application)

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval for manufacturing changes to methylene blue intravenous solutions; confirms compliance with Chemistry, Manufacturing, and Controls standards but does not report clinical efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-31

Application numberANDA215636

Submission typeSupplement (Manufacturing CMC)

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
Manufacturing approval does not indicate comparative benefit or clinical superiority over other formulations.
No information provided on specific manufacturing changes or quality improvements.
Record does not report indications, dosing recommendations, or patient population affected.

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 record; no clinical study design.

Directness

insufficient

Manufacturing CMC approval; does not directly address clinical outcomes.

Consistency

insufficient

Single regulatory submission; no comparative data reported.

Risk of bias

insufficient

Regulatory compliance record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample; manufacturing CMC submission only.

Source abstract

Drugs@FDA record for application ANDA215636. This is a regulatory action record, not a clinical study. Brand name: METHYLENE BLUE. Active ingredient: METHYLENE BLUE. Sponsor: ZYDUS LIFESCIENCES. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-03-31. Products: METHYLENE BLUE, SOLUTION, INTRAVENOUS, METHYLENE BLUE 5MG/ML (5MG/ML); METHYLENE BLUE, SOLUTION, INTRAVENOUS, METHYLENE BLUE 10MG/2ML (5MG/ML); METHYLENE BLUE, SOLUTION, INTRAVENOUS, METHYLENE BLUE 100MG/10ML (10MG/ML); METHYLENE BLUE, SOLUTION, INTRAVENOUS, METHYLENE BLUE 50MG/10ML (5MG/ML).

Follow from this

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

Zydus LifesciencesMethylene Blue