Dapagliflozin · Regulatory approval

FDA approval: Dapagliflozin

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

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

The FDA approved dapagliflozin generic tablets (5 mg and 10 mg) via ANDA application ANDA211523 on 6 April 2026, manufactured by Aizant. This is a regulatory action document that does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory approval. Intervention: Dapagliflozin 5 mg tablet, oral; Dapagliflozin 10 mg tablet, oral.

Key findings

Dapagliflozin 5 mg tablet formulation approved Dapagliflozin 10 mg tablet formulation approved Approval date: 6 April 2026

Safety

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or adverse event summaries. No comparative clinical data, bioequivalence study results, or safety profile are reported in this document.

Who this may help

This approval permits marketing of generic dapagliflozin in two oral tablet strengths. Clinicians should refer to the approved product labeling and existing clinical evidence for dapagliflozin to inform prescribing decisions; this record itself does not provide efficacy or safety data.

Plain-language summary

FDA approval of dapagliflozin generic formulations; regulatory action does not evaluate clinical efficacy or comparative benefit.

Study design

As stated by the source record.

InterventionDapagliflozin 5 mg tablet, oral; Dapagliflozin 10 mg tablet, oral

Reported figures

Quoted from the source exactly as published.

Approval status date2026-04-06

Strengths approved5 mg, 10 mg

Clinical bottom line

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or adverse event summaries.
No comparative clinical data, bioequivalence study results, or safety profile are reported in this document.
Indication(s) and approved use(s) are not specified in the source text.
No information on manufacturing site, approval pathway rationale, or post-market surveillance plans is provided.

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 approval record; no clinical study design reported.

Directness

insufficient

Record documents approval action only; no clinical outcomes data.

Consistency

insufficient

Single regulatory action; no comparative efficacy or safety data.

Risk of bias

insufficient

Regulatory record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No human subject data or sample size reported in approval record.

Source abstract

Drugs@FDA record for application ANDA211523. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN. Active ingredient: DAPAGLIFLOZIN. Sponsor: AIZANT. Submission type: ORIG (original application). Approval status date: 2026-04-06. Products: DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 10MG; DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 5MG.

Follow from this

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

DapagliflozinAizant