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FDA NDA · NDA218475

EPINEPHRINE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA218475
TYPE
NDA
ORIGINAL APPROVAL
2025-02-28
LATEST ACTION
2025-02-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferenceDiscontinued
EPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) · SOLUTION · INTRAVENOUS
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · ReferencePrescription
EPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-09-29Manufacturing (CMC) · Supplement 1LetterTA
2025-02-28Type 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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