Dapagliflozin · Regulatory approval

FDA approval: Dapagliflozin

U.S. Food and Drug Administration · April 6, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA approval of a generic dapagliflozin product (5 mg and 10 mg tablets) under an abbreviated new drug application. The record documents regulatory action only and does not contain clinical trial data, efficacy results, or comparative safety information.

What was studied

Regulatory approval.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA approval of a generic dapagliflozin formulation; regulatory action does not establish comparative efficacy or clinical superiority.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-04-06

Application numberANDA211478

Product strengths approved5 mg and 10 mg tablets, oral

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or comparative safety outcomes.
No information on study design, population, sample size, or endpoints is provided.
Approval under ANDA (abbreviated new drug application) indicates bioequivalence to an existing approved dapagliflozin formulation, not de novo efficacy demonstration.

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 record; no clinical trial design reported.

Directness

insufficient

Regulatory approval record does not report clinical outcomes.

Consistency

insufficient

No comparative data or outcomes reported in this record.

Risk of bias

insufficient

Regulatory record; trial methodology and bias assessment not included.

Sample adequacy

insufficient

No sample size or trial population described 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 ANDA211478. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN. Active ingredient: DAPAGLIFLOZIN. Sponsor: MSN. Submission type: ORIG (original application). Approval status date: 2026-04-06. Products: DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 5MG; DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 10MG.

Follow from this

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

DapagliflozinMSN