← FDA DRUG APPROVALS

FDA NDA · NDA208109

PALONOSETRON HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA208109
TYPE
NDA
ORIGINAL APPROVAL
2017-11-21
LATEST ACTION
2018-12-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PALONOSETRON HYDROCHLORIDE · ReferenceDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2018-12-06Efficacy · Supplement 1 · standard — Label ↗AP
2017-11-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →