Sodium Bicarbonate · Regulatory approval

FDA approval: Sodium Bicarbonate (Type 5 - New Formulation or New Manufacturer)

U.S. Food and Drug Administration · July 9, 2026

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AI Summary

The FDA approved a new intravenous formulation of sodium bicarbonate (150 mEq/1000 mL) manufactured by Amneal on 9 July 2026 under Type 5 NDA 220790. This is a regulatory decision based on manufacturing and formulation standards, not clinical efficacy evidence. The approval action itself does not report or compare clinical trial outcomes.

What was studied

Regulatory approval.

Key findings

Approval date: 2026-07-09 (NDA220790) Product: sodium bicarbonate intravenous solution 150 mEq/1000 mL (0.15 mEq/mL) Manufacturer: Amneal

Safety

This record contains no clinical trial data, efficacy outcomes, or safety results. Type 5 submission (new formulation/manufacturer) does not require de novo clinical trials; approval is based on pharmaceutical equivalence standards.

Who this may help

This is a manufacturing/formulation approval, not a clinical efficacy determination. Clinicians should rely on the established safety and efficacy profile of sodium bicarbonate already in clinical use; this approval does not constitute new clinical evidence.

Plain-language summary

FDA approval of a new formulation/manufacturer of sodium bicarbonate solution for intravenous use; this is a regulatory action, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-09

Concentration150 mEq/1000 mL (0.15 mEq/mL)

NDA number220790

Clinical bottom line

Caveats

This record contains no clinical trial data, efficacy outcomes, or safety results.
Type 5 submission (new formulation/manufacturer) does not require de novo clinical trials; approval is based on pharmaceutical equivalence standards.
No comparative efficacy, adverse event rates, or patient population data are reported.
This approval action does not supersede or modify the established clinical indications or contraindications for sodium bicarbonate.

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 described.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy data.

Consistency

insufficient

Single approval action; no comparative or consistency data provided.

Risk of bias

insufficient

Regulatory record does not disclose clinical trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical sample size or population data reported in approval record.

Source abstract

Drugs@FDA record for application NDA220790. This is a regulatory action record, not a clinical study. Brand name: SODIUM BICARBONATE. Active ingredient: SODIUM BICARBONATE. Sponsor: AMNEAL. Submission type: ORIG (original application). Submission class: Type 5 - New Formulation or New Manufacturer. Approval status date: 2026-07-09. Products: SODIUM BICARBONATE, SOLUTION, INTRAVENOUS, SODIUM BICARBONATE 150MEQ/1000ML (0.15MEQ/ML).

Follow from this

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

AmnealSodium Bicarbonate