Acyclovir · Regulatory label update

FDA supplemental approval: Acyclovir (Labeling)

U.S. Food and Drug Administration · June 24, 2026

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

The FDA approved a supplemental application (ANDA212173) on 24 June 2026 for a labeling change to acyclovir 200 mg capsules manufactured by YILING. This is a regulatory action only and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Safety

No safety or efficacy outcomes are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for acyclovir labeling update; this is a regulatory action record without clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-24

Product strength200 mg

Caveats

This record does not contain clinical trial results or efficacy data.
The specific nature of the labeling change is not disclosed in this record.
No safety or efficacy outcomes are reported.
No comparator arm or comparative benefit is described.

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

This is a regulatory action, not a clinical study.

Directness

insufficient

Labeling supplement does not report clinical outcomes or direct evidence.

Consistency

insufficient

No comparative data provided in this record.

Risk of bias

insufficient

Not applicable to regulatory labeling action.

Sample adequacy

insufficient

No patient population or sample size in this record.

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 ANDA212173. This is a regulatory action record, not a clinical study. Brand name: ACYCLOVIR. Active ingredient: ACYCLOVIR. Sponsor: YILING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-24. Products: ACYCLOVIR, CAPSULE, ORAL, ACYCLOVIR 200MG.

Follow from this

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

YilingAcyclovir