FDA NDA · NDA218524

SODIUM BICARBONATE

Sponsor: BAXTER HLTHCARE CORP

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APPLICATION
NDA218524
TYPE
NDA
ORIGINAL APPROVAL
2026-08-14
LATEST ACTION
2026-10-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SODIUM BICARBONATE · ReferencePrescription
SODIUM BICARBONATE 150MEQ/1000ML (0.15MEQ/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-10-06Labeling · Supplement 1 · standard — Letter ↗AP
2026-08-14Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP