Carbidopa · Regulatory label update

FDA supplemental approval: Carbidopa AND Levodopa (Labeling)

U.S. Food and Drug Administration · May 28, 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 carbidopa–levodopa fixed-dose tablets (three formulations) submitted by Apotex Inc. on 28 May 2026. The record does not contain clinical trial data, efficacy evidence, safety findings, or details of the labeling modification itself.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for carbidopa–levodopa tablets: 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg oral formulations Applicant: Apotex Inc.; submission class: labeling only

Safety

This record reports regulatory action only and contains no clinical trial results, efficacy data, or safety findings. The record does not indicate whether this is a new indication, a safety update, or a manufacturing/formulation change.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for an established combination product; does not report clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-28

ANDA number077120

Caveats

This record reports regulatory action only and contains no clinical trial results, efficacy data, or safety findings.
The specific labeling changes approved are not detailed in this record.
No comparative efficacy, absolute risk reduction, hazard ratios, or p-values are reported.
The record does not indicate whether this is a new indication, a safety update, or a manufacturing/formulation change.

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 study design reported.

Directness

insufficient

Labeling action only; no clinical endpoints or patient outcomes reported.

Consistency

insufficient

No comparative data or prior trials cited in this record.

Risk of bias

insufficient

Regulatory approval record; clinical trial risk assessment not applicable.

Sample adequacy

insufficient

No sample size, trial population, or patient data reported.

Source abstract

Drugs@FDA record for application ANDA077120. This is a regulatory action record, not a clinical study. Brand name: CARBIDOPA AND LEVODOPA. Active ingredient: CARBIDOPA. Sponsor: APOTEX INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-28. Products: CARBIDOPA AND LEVODOPA, TABLET, ORAL, CARBIDOPA 10MG + LEVODOPA 100MG; CARBIDOPA AND LEVODOPA, TABLET, ORAL, CARBIDOPA 25MG + LEVODOPA 100MG; CARBIDOPA AND LEVODOPA, TABLET, ORAL, CARBIDOPA 25MG + LEVODOPA 250MG.

Follow from this

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

CarbidopaApotex