Last Updated: November 8, 2026

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, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.

The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There is one drug master file entry for this compound. Fifteen 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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