Sodium Bicarbonate · Regulatory approval

FDA approval: Sodium Bicarbonate

U.S. Food and Drug Administration · July 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 an original application (ANDA219089) for sodium bicarbonate 50 mEq/50 mL intravenous solution manufactured by Milla Pharms, effective 6 July 2026. This is a regulatory action record and does not include clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory approval.

Key findings

FDA approval granted for sodium bicarbonate intravenous solution, 50 mEq/50 mL (1 mEq/mL concentration)

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness

Who this may help

Clinicians should consult the approved product labeling, prescribing information, and FDA guidance for appropriate use, dosing, contraindications, and adverse event monitoring. This approval does not convey efficacy or comparative benefit; those claims depend on clinical evidence not reported here.

Plain-language summary

FDA approval action for a sodium bicarbonate intravenous solution; regulatory records do not report clinical trial efficacy or comparative outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-06

Formulation strength50 mEq/50 mL

Concentration1 mEq/mL

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness
No information on indication, dosing recommendations, or contraindications is provided in this regulatory action record
Study design, sample size, and study population are not applicable to regulatory approval records

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

No clinical outcome data; approval record only

Consistency

insufficient

No comparative efficacy or safety data provided

Risk of bias

insufficient

Regulatory action; clinical trial bias assessment not applicable

Sample adequacy

insufficient

No sample size or study population data reported

Source abstract

Drugs@FDA record for application ANDA219089. This is a regulatory action record, not a clinical study. Brand name: SODIUM BICARBONATE. Active ingredient: SODIUM BICARBONATE. Sponsor: MILLA PHARMS. Submission type: ORIG (original application). Approval status date: 2026-07-06. Products: SODIUM BICARBONATE, SOLUTION, INTRAVENOUS, SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML).

Follow from this

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

Milla PharmsSodium Bicarbonate