Clonazepam · Regulatory label update

FDA supplemental approval: Clonazepam (Manufacturing (CMC))

U.S. Food and Drug Administration · June 12, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental application (ANDA075468) submitted by Rubicon Research on 12 June 2026 for manufacturing and controls (CMC) changes to clonazepam tablets in four strengths (0.25 mg, 0.5 mg, 1 mg, 2 mg). This is a manufacturing/chemistry approval and does not contain clinical trial data, efficacy evidence, or safety outcomes.

What was studied

Regulatory label update.

Key findings

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 clonazepam tablets; no clinical efficacy or safety data reported.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-12

Application typeANDA supplement (Manufacturing/CMC)

Approved strengths0.25 mg, 0.5 mg, 1 mg, 2 mg tablets

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
Approval is limited to manufacturing, chemistry, and controls (CMC); no clinical comparisons or effectiveness claims are reported.
No information on the nature of the manufacturing changes, specifications, or rationale for the supplement is provided in this record.

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 and CMC record does not address clinical endpoints.

Consistency

insufficient

No comparative data or prior results reported in this record.

Risk of bias

insufficient

Not applicable to manufacturing approval; no trial conduct reported.

Sample adequacy

insufficient

No patient population or sample size in manufacturing submission.

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 ANDA075468. This is a regulatory action record, not a clinical study. Brand name: CLONAZEPAM. Active ingredient: CLONAZEPAM. Sponsor: RUBICON RESEARCH. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-06-12. Products: CLONAZEPAM, TABLET, ORAL, CLONAZEPAM 0.5MG; CLONAZEPAM, TABLET, ORAL, CLONAZEPAM 0.25MG; CLONAZEPAM, TABLET, ORAL, CLONAZEPAM 1MG; CLONAZEPAM, TABLET, ORAL, CLONAZEPAM 2MG.

Follow from this

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

Rubicon ResearchClonazepam