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FDA NDA · NDA021372

PALONOSETRON HYDROCHLORIDE

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APPLICATION
NDA021372
TYPE
NDA
ORIGINAL APPROVAL
2003-07-25
LATEST ACTION
2020-04-01
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ALOXI · ReferenceDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
ALOXI · ReferenceDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2020-04-01Labeling · Supplement 21 · standard — Letter ↗AP
2014-09-18Labeling · Supplement 20 · 901 required — Letter ↗AP
2014-05-27Efficacy · Supplement 18 · priority — Pediatric Medical Review ↗AP
2014-05-27Efficacy · Supplement 19 · priority — Pediatric Medical Review ↗AP
2014-02-06Labeling · Supplement 17 · standard — Letter ↗AP
2008-02-29Efficacy · Supplement 10 · unknown — Review ↗AP
2008-02-29Efficacy · Supplement 8 · unknown — Letter ↗AP
2007-08-30Efficacy · Supplement 6 · standard — Label ↗AP
2006-08-23Labeling · Supplement 5 · standard — Letter ↗AP
2005-07-05Labeling · Supplement 2 · standard — Letter ↗AP
2003-07-25Type 1 - New Molecular Entity · Original · standard — Pediatric Written Request ↗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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