Lithium Carbonate · Regulatory label update

FDA supplemental approval: Lithium Carbonate (Labeling)

U.S. Food and Drug Administration · July 13, 2026

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

This is an FDA supplemental approval for a labeling change to lithium carbonate 300 mg extended-release tablets (ANDA076832, sponsor Hikma), approved 13 July 2026. The record confirms regulatory action but does not report clinical trial outcomes, efficacy data, or comparative benefit.

What was studied

Regulatory label update.

Key findings

Safety

No safety, efficacy, or clinical performance data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling changes to an established lithium carbonate product; no clinical trial data or efficacy comparisons are provided in this regulatory record.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-13

Product strengthLITHIUM CARBONATE 300MG

Dosage formTABLET, EXTENDED RELEASE, ORAL

Caveats

This record reports a regulatory labeling supplement only and does not contain clinical trial results, efficacy data, or comparative outcome measures.
No information on what labeling changes were made or their rationale is provided in the source text.
No safety, efficacy, or clinical performance data are reported.

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 action record; no study design applicable.

Directness

insufficient

Labeling supplement only; does not report clinical outcomes or comparisons.

Consistency

insufficient

Single regulatory action; no comparative or consistency data provided.

Risk of bias

insufficient

Not a clinical trial; risk of bias framework does not apply.

Sample adequacy

insufficient

No population studied; regulatory approval record only.

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 ANDA076832. This is a regulatory action record, not a clinical study. Brand name: LITHIUM CARBONATE. Active ingredient: LITHIUM CARBONATE. Sponsor: HIKMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-13. Products: LITHIUM CARBONATE, TABLET, EXTENDED RELEASE, ORAL, LITHIUM CARBONATE 300MG.

Follow from this

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

Lithium CarbonateHikma