← FDA DRUG APPROVALS

FDA NDA · NDA022325

NEXTERONE

amiodarone hydrochloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA022325
TYPE
NDA
ORIGINAL APPROVAL
2008-12-24
LATEST ACTION
2025-02-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

NEXTERONE · ReferencePrescription
AMIODARONE HYDROCHLORIDE 360MG/200ML (1.8MG/ML) · INJECTABLE · INJECTION
NEXTERONE · ReferenceDiscontinued
AMIODARONE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NEXTERONE · ReferencePrescription
AMIODARONE HYDROCHLORIDE 150MG/100ML (1.5MG/ML) · INJECTABLE · INJECTION

Approval history

2025-02-21Labeling · Supplement 19 · standard — Letter ↗AP
2021-09-07Labeling · Supplement 16 · standard — Letter ↗AP
2017-03-22Labeling · Supplement 14 · standard — Letter ↗AP
2016-11-22Labeling · Supplement 13 · standard — Letter ↗AP
2016-10-31Manufacturing (CMC) · Supplement 12 · standardAP
2015-03-13Labeling · Supplement 9 · standard — Letter ↗AP
2014-09-29Manufacturing (CMC) · Supplement 10 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 5 · standardAP
2013-08-23Manufacturing (CMC) · Supplement 7 · standardAP
2013-04-29Manufacturing (CMC) · Supplement 8 · standardAP
2013-04-05Manufacturing (CMC) · Supplement 6 · standardAP
2013-01-04Manufacturing (CMC) · Supplement 4 · standardAP
2011-12-12Labeling · Supplement 2 · unknown — Label ↗AP
2010-11-16Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
2008-12-24Type 3 - New Dosage Form · 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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