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 twenty-eight drug master file entries for this compound. Thirty-six 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
Approval Date:	Jan 24, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020605

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	4,695,578*PED	⤷ Subscribe
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	5,854,270*PED	⤷ Subscribe
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	4,753,789*PED	⤷ Subscribe
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	5,578,628*PED	⤷ Subscribe
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