Dapagliflozin AND Metformin Hydrochloride · Regulatory approval

FDA approval: Dapagliflozin AND Metformin Hydrochloride

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

The FDA approved a generic fixed-dose combination tablet containing dapagliflozin and metformin hydrochloride (ANDA 211559) on 6 April 2026. This regulatory action does not include clinical trial data, efficacy comparisons, or safety results; it confirms that the applicant met FDA standards for bioequivalence and manufacturing quality for a generic product.

What was studied

Regulatory approval. Patients eligible for dapagliflozin and metformin combination therapy; population characteristics not detailed in regulatory record..

Key findings

FDA approval granted for dapagliflozin 5 mg + metformin HCl 500 mg extended-release tablet FDA approval granted for dapagliflozin 10 mg + metformin HCl 500 mg extended-release tablet FDA approval granted for dapagliflozin 5 mg + metformin HCl 1 g extended-release tablet

Safety

No comparative safety or efficacy data are reported; approval reflects bioequivalence and quality standards only. Approval date: 2026-04-06; Sponsor: MacLeods Pharmaceuticals Ltd

Who this may help

This approval makes a generic fixed-dose combination available; it does not establish clinical superiority or new efficacy data. Clinicians should refer to existing evidence for the two agents and their combination. The approval confirms manufacturing and bioequivalence standards met FDA requirements.

Plain-language summary

FDA approval of a generic fixed-dose combination of dapagliflozin and metformin; this is a regulatory action record that does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Dapagliflozin dose (low strength)5 mg

Dapagliflozin dose (high strength)10 mg

Metformin HCl dose (low strength)500 mg

Metformin HCl dose (high strength)1 g

Approval date2026-04-06

Clinical bottom line

Caveats

This record does not contain clinical trial results or efficacy data.
No comparative safety or efficacy data are reported; approval reflects bioequivalence and quality standards only.
No information on patient population, study design, or clinical outcomes is provided.
This is a generic ANDA approval; it does not establish new clinical indications or contraindications beyond those of the reference products.

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.

Directness

insufficient

Regulatory approval record; no clinical outcome data reported.

Consistency

insufficient

No clinical trial data; consistency cannot be assessed.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No clinical trial population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA211559. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Active ingredient: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Sponsor: MACLEODS PHARMS LTD. Submission type: ORIG (original application). Approval status date: 2026-04-06. Products: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 500MG; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 5MG + METFORMIN HYDROCHLORIDE 500MG; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 1GM; DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 5MG + METFORMIN HYDROCHLORIDE 1GM.

Follow from this

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

Macleods PharmsDapagliflozin AND Metformin Hydrochloride