Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218524
Company: BAXTER HLTHCARE CORP

Products on NDA 218524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM BICARBONAT	SODIUM BICARBONAT	12.6MG/ML (0.150MEQ/ML)	VIAL;SINGLE-DOSE	For Further Manufacturing Use	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2026	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218524Orig1s001ltr.pdf