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FDA NDA · NDA215700

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

norepinephrine bitartrate

Sponsor: INFORLIFE

APPLICATION
NDA215700
TYPE
NDA
ORIGINAL APPROVAL
2022-09-15
LATEST ACTION
2023-07-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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 0.9% SODIUM CHLORIDE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) · SOLUTION · INTRAVENOUS
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-07-27Labeling · Supplement 2 · standard — Letter ↗AP
2023-02-06Labeling · Supplement 1 · standard — Letter ↗AP
2022-09-15Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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