Last Updated: September 29, 2026

Details for New Drug Application (NDA): 077551

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NDA 077551 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Onesource Specialty, Sandoz, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, and Wockhardt Bio Ag, and is included in twenty NDAs. It is available from eleven suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 077551

Tradename:	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:	Sandoz
Ingredient:	ondansetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Jun 27, 2007	TE:	AP	RLD:	No

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