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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208109

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NDA 208109 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.

The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for 208109

Tradename:	PALONOSETRON HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	palonosetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:	Nov 21, 2017	TE:		RLD:	Yes

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