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FDA NDA · NDA214628

NOREPINEPHRINE

norepinephrine bitartrate

Sponsor: LONG GROVE PHARMS

APPLICATION
NDA214628
TYPE
NDA
ORIGINAL APPROVAL
2022-10-06
LATEST ACTION
2024-12-03
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 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

Approval history

2024-12-03Manufacturing (CMC) · Supplement 4 — Label ↗AP
2022-10-06Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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