Details for New Drug Application (NDA): 020007

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NDA 020007 describes ZOFRAN PRESERVATIVE FREE, which is a drug marketed by Sandoz and is included in one NDA. Additional details are available on the ZOFRAN PRESERVATIVE FREE profile page.

The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 020007

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 4, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 10, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020007

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991	⤷ Sign Up	⤷ Sign Up
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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