Drug or technology

Sodium Bicarbonate

2 developments in the corpus

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JUL 9, 2026 · REGULATORY APPROVAL

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

U.S. Food and Drug Administration

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

Insufficient InformationAmneal Sodium Bicarbonate

Reported

Approval date2026-07-09

Concentration150 mEq/1000 mL (0.15 mEq/mL)

NDA number220790

JUL 6, 2026 · REGULATORY APPROVAL

FDA approval: Sodium Bicarbonate

U.S. Food and Drug Administration

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

Regulatory UpdateMilla Pharms Sodium Bicarbonate

Reported

Approval date2026-07-06

Formulation strength50 mEq/50 mL

Concentration1 mEq/mL