Amlodipine AND Atorvastatin · Regulatory label update

FDA supplemental approval: Amlodipine AND Atorvastatin (Labeling)

U.S. Food and Drug Administration · June 25, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a regulatory record documenting FDA approval of a supplemental labeling change for a fixed-dose combination tablet of amlodipine and atorvastatin by Mylan (ANDA200465), approved on 25 June 2026. The record describes the product formulations and approval action only; it does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Approval of labeling supplement for amlodipine and atorvastatin combination product in four formulations: 2.5/10 mg, 2.5/40 mg, 5/20 mg, and 10/80 mg base equivalents

Safety

This record does not contain clinical trial results, efficacy endpoints, safety data, or comparative evidence. No information on indication, dosing recommendations, contraindications, or adverse event profile is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for a fixed-dose combination of amlodipine and atorvastatin; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-25

Application numberANDA200465

Formulation 1Amlodipine 2.5 mg base + Atorvastatin 10 mg base

Formulation 2Amlodipine 2.5 mg base + Atorvastatin 40 mg base

Formulation 3Amlodipine 5 mg base + Atorvastatin 20 mg base

Formulation 4Amlodipine 10 mg base + Atorvastatin 80 mg base

Caveats

This record does not contain clinical trial results, efficacy endpoints, safety data, or comparative evidence.
The specific content of the labeling change is not disclosed in this regulatory record.
No information on indication, dosing recommendations, contraindications, or adverse event profile 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

This is a regulatory record, not a clinical study.

Directness

insufficient

Record describes labeling approval only; no clinical trial or outcome data.

Consistency

insufficient

No comparative or replication data reported in this regulatory record.

Risk of bias

insufficient

Not applicable to a regulatory labeling action.

Sample adequacy

insufficient

Not applicable; this record does not report a clinical trial.

Source abstract

Drugs@FDA record for application ANDA200465. This is a regulatory action record, not a clinical study. Brand name: AMLODIPINE AND ATORVASTATIN. Active ingredient: AMLODIPINE AND ATORVASTATIN. Sponsor: MYLAN. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-25. Products: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, TABLET, ORAL, AMLODIPINE BESYLATE EQ 5MG BASE + ATORVASTATIN CALCIUM EQ 20MG BASE; AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, TABLET, ORAL, AMLODIPINE BESYLATE EQ 10MG BASE + ATORVASTATIN CALCIUM EQ 80MG BASE; AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, TABLET, ORAL, AMLODIPINE BESYLATE EQ 2.5MG BASE + ATORVASTATIN CALCIUM EQ 40MG BASE; AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, TABLET, ORAL, AMLODIPINE BESYLATE EQ 2.5MG BASE + ATORVASTATIN CALCIUM EQ 10MG BASE.

Follow from this

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

Amlodipine AND AtorvastatinMylan