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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020403

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NDA 020403 describes ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 020403

Tradename:	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Applicant:	Glaxosmithkline
Ingredient:	ondansetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 31, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020403

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995	4,695,578*PED	⤷ Get Started Free
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995	5,578,628*PED	⤷ Get Started Free
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995	4,753,789*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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