← FDA DRUG APPROVALS

FDA NDA · NDA022233

ALOXI

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APPLICATION
NDA022233
TYPE
NDA
ORIGINAL APPROVAL
2008-08-22
LATEST ACTION
2020-04-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ALOXI · ReferenceDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2020-04-01Labeling · Supplement 6 · standard — Letter ↗AP
2014-09-18Labeling · Supplement 5 · 901 required — Letter ↗AP
2008-08-22Type 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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