Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020605

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NDA 020605 describes ZOFRAN, which is a drug marketed by Sandoz and Glaxosmithkline and is included in five NDAs. Additional details are available on the ZOFRAN profile page.

The generic ingredient in ZOFRAN is ondansetron. There are two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

Summary for 020605

Tradename:	ZOFRAN
Applicant:	Sandoz
Ingredient:	ondansetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 24, 1997	TE:		RLD:	Yes

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