Last Updated: September 8, 2026

Details for New Drug Application (NDA): 207963

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NDA 207963 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 207963

Tradename:	PALONOSETRON HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	palonosetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)
Approval Date:	Aug 22, 2016	TE:		RLD:	No

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