Diazepam · Regulatory approval

FDA approval: Diazepam

U.S. Food and Drug Administration · July 27, 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 an abbreviated new drug application (ANDA) for diazepam injectable 10 mg/2 mL (5 mg/mL) manufactured by Lupin on 27 July 2026. This regulatory action documents authorization of a generic formulation but does not contain clinical trial data, efficacy comparisons, or safety evidence; the approval is based on bioequivalence and manufacturing standards established through the ANDA pathway.

What was studied

Regulatory approval.

Key findings

FDA approval granted for diazepam injectable formulation 10 mg/2 mL (5 mg/mL) on approval status date 2026-07-27 Application type: ANDA (abbreviated new drug application) ANDA220365 Sponsor: Lupin

Safety

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes No adverse event profile, contraindications, or dosing recommendations are stated in this approval record

Who this may help

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

Plain-language summary

This is an FDA approval action for a generic diazepam injectable formulation; it documents regulatory authorization, not clinical trial evidence or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-27

Formulation strength10 mg/2 mL (5 mg/mL)

Route of administrationInjectable injection

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes
No comparative efficacy or bioequivalence study details are provided in this approval notice
The approval basis (bioequivalence to reference product) is not detailed in this record
No adverse event profile, contraindications, or dosing recommendations are stated in this approval 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

This is a regulatory record, not a clinical study design.

Directness

insufficient

Record contains no clinical outcome data or trial results.

Consistency

insufficient

No comparative data or multiple studies presented in this record.

Risk of bias

insufficient

Regulatory approval record does not report clinical trial methodology.

Sample adequacy

insufficient

No patient population or sample size disclosed in this approval notice.

Source abstract

Drugs@FDA record for application ANDA220365. This is a regulatory action record, not a clinical study. Brand name: DIAZEPAM. Active ingredient: DIAZEPAM. Sponsor: LUPIN. Submission type: ORIG (original application). Approval status date: 2026-07-27. Products: DIAZEPAM, INJECTABLE, INJECTION, DIAZEPAM 10MG/2ML (5MG/ML).

Follow from this

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

LupinDiazepam