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FDA NDA · NDA214313

NOREPINEPHRINE BITARTRATE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA214313
TYPE
NDA
ORIGINAL APPROVAL
2021-01-15
LATEST ACTION
2026-02-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-06Manufacturing (CMC) · Supplement 8LetterAP
2024-06-11Manufacturing (CMC) · Supplement 4LetterAP
2023-11-23Manufacturing (CMC) · Supplement 3LetterAP
2022-06-02Manufacturing (CMC) · Supplement 1LetterAP
2022-06-02Manufacturing (CMC) · Supplement 2 · standardLabelAP
2021-01-15Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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