Issued to BAXTER HLTHCARE CORP. Application is approved as submitted.
Issued
February 9, 2026Application
NDA 505b1 • 214313
Product
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE / NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Company
BAXTER HLTHCARE CORP
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-02-09. The source metadata identifies NDA 214313 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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This letter documents an FDA approval action: FDA approved NDA 214313 for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE / NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, sponsored by BAXTER HLTHCARE CORP, on February 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 214313 is the application under which FDA issued this approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE / NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE to BAXTER HLTHCARE CORP. The letter is dated February 9, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.